Clinical trial • Phase III • Oncology

5,8-DICHLORO-2-[(4-METHOXY-6-METHYL-2-OXO-1,2-DIHYDROPYRIDIN-3-YL)METHYL]-7-[(R)-METHOXY(OXETAN-3-YL)METHYL]-3,4-DIHYDROISOQUINOLIN-1(2H)-ONE for Metastatic castration-sensitive prostate cancer

Phase III trial of 5,8-DICHLORO-2-[(4-METHOXY-6-METHYL-2-OXO-1,2-DIHYDROPYRIDIN-3-YL)METHYL]-7-[(R)-METHOXY(OXETAN-3-YL)METHYL]-3,4-DIHYDROISOQUINOLIN-1(2…

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Metastatic castration-sensitive prostate cancer
Trial Stage: Phase III
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 27-08-2025
First CTIS Authorization Date: 22-12-2025

Trial design

Randomised, placebo (tablet to match pf-06821497 125 mg or 250 mg) plus enzalutamide (xtandi - 40 mg soft capsules; product max daily dose 160 mg as per product information). investigational arm: pf-06821497 (oral tablet) in combination with enzalutamide.-controlled Phase III trial in Belgium, Czechia, France and others.

Randomised: Yes
Comparator: Placebo (tablet to match PF-06821497 125 mg or 250 mg) plus enzalutamide (Xtandi - 40 mg soft capsules; product max daily dose 160 mg as per product information). Investigational arm: PF-06821497 (oral tablet) in combination with enzalutamide.
Target Sample Size: 907

Eligibility

Recruits 907 No vulnerable populations selected. Participants are adult males (≥18 years) and consent is obtained from the participant. Country/language-specific informed consent documents are provided; separate "Pregnant Partner ICF" documents are present for managing pregnant partners..

Vulnerable Population: No vulnerable populations selected. Participants are adult males (≥18 years) and consent is obtained from the participant. Country/language-specific informed consent documents are provided; separate "Pregnant Partner ICF" documents are present for managing pregnant partners.

Inclusion criteria

{"criterion_text":"- Male participants aged 18 years of age or older (or the minimum age of consent in accordance with local regulations) at screening."}
{"criterion_text":"- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features (neuroendocrine differentiation and other histologic components are permitted if adenocarcinoma is the primary histology). For participants without a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis."}
{"criterion_text":"- Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI scan (for soft tissue/visceral disease)."}
{"criterion_text":"- Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator’s judgment)."}
{"criterion_text":"- Participants cannot have received any cytotoxic chemotherapy, ARPIs (eg, enzalutamide, apalutamide, abiraterone acetate, or darolutamide), any other systemic anticancer therapies for mCSPC, with the following exceptions: a.ADT (chemical or surgical) must be started prior to randomization and must continue throughout the study. Prior therapy with up to 3 months of ADT (with or without antiandrogens) is allowed with no radiographic evidence of disease progression or rising PSA levels indicative of disease progression prior to Day 1.; b. Treatment with estrogens, cyproterone acetate or first-generation antiandrogens is allowed until randomization, but must be discontinued prior to randomization.; c. Participants may have received 1 course of palliative radiation or surgery for symptomatic control secondary to prostate cancer, which should be completed at least 2 weeks prior to randomization."}
{"criterion_text":"- Participants must have ECOG PS 0 or 1."}

Exclusion criteria

{"criterion_text":"- Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study."}
{"criterion_text":"- Inability to swallow oral medications."}
{"criterion_text":"- Clinically significant cardiovascular disease, defined as: Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, or symptomatic pulmonary embolism or other clinically significant episode of thromboembolic disease, congenital long QT syndrome, Torsade de Pointes, clinically important arrhythmias, left anterior hemiblock (bifascicular block), ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, or other clinically significant cardiovascular disease as assessed by the investigator. If a participant has a cardiac rhythm device/pacemaker placed and QTcF >470 ms, the participant may be considered eligible. QTcF >480 ms on screening ECG."}
{"criterion_text":"- CNS pathology/neurological findings: a.Known or suspected brain metastasis or active leptomeningeal disease; b.Symptomatic or impending spinal cord compression or cauda equina syndrome; c.Participants with epidural disease, canal disease and prior cord involvement are NOT excluded if those areas have been treated, are stable and not neurologically impaired; d. Clinically significant history of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma). Also history of unexplained loss of consciousness or transient ischemic attack within 12 months of randomization."}
{"criterion_text":"- Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy except for any of the following: a.Carcinoma in situ or nonmelanoma skin cancer.; b.Any prior malignancies ≥3 years before randomization with no subsequent evidence of recurrence or progression regardless of the stage; c. Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence or progression in the opinion of the investigator."}
{"criterion_text":"- In the opinion of the investigator, any clinically significant gastrointestinal disorder affecting absorption."}
{"criterion_text":"- Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients."}
{"criterion_text":"- Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s)."}
{"criterion_text":"- Prior treatment with: a.ADT in the adjuvant/neoadjuvant setting, where the completion of ADT was <12 months prior to randomization and the total duration of ADT was >36 months; b. ARPI’s such as abiraterone, apalutamide, darolutamide, enzalutamide or other investigational ARPI’s; c.Cytochrome P17 enzyme inhibitors such as oral ketoconazole as anticancer treatments for prostate cancer; d. Chemotherapy including docetaxel or immunotherapy for prostate cancer.; e. Radiopharmaceuticals (ie, 177Lu-PSMA-617, radium-223); f. CDK4/6 inhibitors; g. Any other anticancer treatment for metastatic prostate cancer, excluding palliative radiotherapy/surgery and ADT as discussed above."}
{"criterion_text":"- Previous administration of an investigational product (drug or vaccine) which does not meet exclusion criterion 7 within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study."}
{"criterion_text":"- Inadequate renal function defined by an eGFR <45 mL/min/1.73 m2. Based upon participant age at screening, eGFR is calculated using the recommended formulas in Appendix 7 Section 10.7.2 to determine eligibility and to provide a baseline to quantify any subsequent kidney safety events. For eligibility assessment based upon estimated renal function, the higher of the screening and baseline eGFR values may be used."}
{"criterion_text":"- Major surgery (as defined by investigator) from which the participant has not fully recovered at least 28 days prior to randomization."}
{"criterion_text":"- Hepatic dysfunction defined as having any 1 of the following, which may be confirmed by a single repeat test, if necessary: a. Total bilirubin ≥1.5 x ULN (≥3 x ULN for participants with documented Gilbert’s syndrome, direct bilirubin >ULN is exclusionary) b. AST >2.5 x ULN c. ALT >2.5 x ULN"}
{"criterion_text":"- Hematologic abnormalities defined as having any 1 of the following, which may be confirmed by a single repeat test, if necessary: a. ANC <1500/mm3; b. Platelets <100,000/mm3, independent of transfusion within 14 days of randomization; c. Hemoglobin <9 g/dL, independent of transfusion within 14 days of randomization"}
{"criterion_text":"- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members."}

Endpoints

Primary endpoints

{"endpoint_text":"- BICR assessed rPFS per RECIST 1.1 (soft tissue disease) and PCWG3 (bone disease)","definition_or_measurement_approach":"Blinded independent central review (BICR) assessment of radiographic progression-free survival using RECIST 1.1 for soft tissue disease and PCWG3 criteria for bone disease (rPFS)"}

Secondary endpoints

{"endpoint_text":"- OS (alpha protected)","definition_or_measurement_approach":"Overall survival (time from randomization to death from any cause); listed as alpha-protected secondary endpoint"}
{"endpoint_text":"- Proportion of participants with measurable soft tissue disease at baseline with an objective response per RECIST 1.1 (assessed by BICR and investigator)","definition_or_measurement_approach":"Objective response per RECIST 1.1 assessed by blinded independent central review (BICR) and investigator assessment in participants with measurable soft tissue disease"}
{"endpoint_text":"- Duration of soft tissue response per RECIST 1.1 (assessed by BICR and investigator)","definition_or_measurement_approach":"Duration of response in soft tissue per RECIST 1.1 by BICR and investigator"}
{"endpoint_text":"- Proportion of participants with prostate-specific antigen (PSA) response ≥50% in participants with detectable PSA values at baseline","definition_or_measurement_approach":"Proportion achieving ≥50% decline in PSA from baseline among those with detectable baseline PSA"}
{"endpoint_text":"- Time to PSA progression","definition_or_measurement_approach":"Time from randomization to PSA progression (as defined in protocol)"}
{"endpoint_text":"- Time to initiation of antineoplastic therapy","definition_or_measurement_approach":"Time from randomization to start of subsequent antineoplastic therapy"}
{"endpoint_text":"- Time to first symptomatic skeletal event","definition_or_measurement_approach":"Time from randomization to first symptomatic skeletal event"}
{"endpoint_text":"- Time from randomization to castration-resistant prostate cancer (CRPC)","definition_or_measurement_approach":"Time from randomization until development of castration-resistant prostate cancer per protocol definition"}
{"endpoint_text":"- Type, incidence, severity (as graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v5.0), seriousness and relationship to study medications of adverse events (AEs) and any laboratory test and electrocardiogram (ECG) abnormalities","definition_or_measurement_approach":"Safety reporting using NCI CTCAE v5.0 for grading AEs; collection of laboratory and ECG abnormalities and assessment of relatedness"}
{"endpoint_text":"- PK characterized by pre-dose trough and post-dose plasma concentrations of mevrometostat at selected visits","definition_or_measurement_approach":"Pharmacokinetic sampling: pre-dose trough and post-dose plasma concentrations of mevrometostat at specified visits"}
{"endpoint_text":"- Change from baseline and time to confirmed deterioration in participantreported worst pain symptoms per Brief Pain Inventory – Short Form (BPI-SF)","definition_or_measurement_approach":"Patient-reported worst pain by BPI-SF: change from baseline and time to confirmed deterioration"}
{"endpoint_text":"- Change from baseline in health-related quality of life (HRQoL), functioning, and symptoms and time to definitive deterioration per Functional Assessment of Cancer Therapy – Prostate (FACT-P)","definition_or_measurement_approach":"FACT-P patient-reported HRQoL: change from baseline and time to definitive deterioration"}
{"endpoint_text":"- Change from baseline and time to definitive deterioration in participantreported prostate cancer specific functioning and symptoms per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Cancer 25 (EORTC QLQ-PR25)","definition_or_measurement_approach":"EORTC QLQ-PR25 prostate-specific QoL/functioning: change from baseline and time to definitive deterioration"}
{"endpoint_text":"- Change from baseline and time to confirmed deterioration in participantreported fatigue symptoms per Brief Fatigue Inventory (BFI)","definition_or_measurement_approach":"Patient-reported fatigue via BFI: change from baseline and time to confirmed deterioration"}
{"endpoint_text":"- Change from baseline in participant-reported general health status per European Quality of Life 5-Dimensions 5-Level (EQ-5D-5L)","definition_or_measurement_approach":"EQ-5D-5L general health status: change from baseline"}
{"endpoint_text":"- ctDNA burden at baseline and on study","definition_or_measurement_approach":"Measurement of circulating tumor DNA (ctDNA) burden at baseline and during study visits"}

Recruitment

Digital Remote Recruitment: True, recruitment materials include digital channels: study webpages, homepage tiles, search engine advertisement text and keywords, QR postcards, patient videos and online programmatic pages; country-specific digital materials are provided in the recruitment documents library.
Planned Sample Size: 907
Recruitment Window Months: 114
Consent Approach: Informed consent is required from each participant (adult males ≥18 years, or minimum local age of consent). Country/language-specific informed consent forms are provided (multiple ICF documents in EN, FR, NL, GR, CZ, DE, ES, IT, PL, SK, BG, FI, etc.). Optional procedure ICFs, retained sample ICFs, Scout ICD and separate "Pregnant Partner ICF" documents are available where applicable. No assent for minors (trial enrols adults).

Methods

Study brochure insert (printed study brochure) – country-specific versions available (documents list includes Study Brochure Insert files for multiple countries). Target audience: men with metastatic castration-sensitive prostate cancer.
Program brochure / programmatic pages / program flyer / program poster (printed and digital materials) – country-specific versions present in recruitment documents.
Study page / Site website / Homepage tile (digital site webpages) – country-specific study pages and homepage tiles documented (e.g., NL, DE, CZ, FI, others).
Search engine advertisement text and keyword lists (digital recruitment via search engines) – country-specific materials present (e.g., DE, NL).
QR post card / QR program postcard (digital entry points via QR codes) – country-specific materials present.
Informed Consent Flipbook and patient-facing videos / patient video storyboards (multimedia recruitment/information) – country-specific patient videos and storyboards are included (e.g., CZ, GR).
Patient-facing printed materials and local outreach (materials labelled for local distribution and patient brochure inserts).

Geography

Total Number Of Sites: 118
Total Number Of Participants: 907

Belgium

Earliest CTIS Part Ii Submission Date: 09-12-2025
Latest Decision Or Authorization Date: 12-01-2026
Processing Time Days: 34
Number Of Sites: 9
Number Of Participants: 40

Sites

Site Name: Ziekenhuis Aan De Stroom
Department Name: Oncology
Principal Investigator Name: Simon Van Wambeke
Principal Investigator Email: simon.vanwambeke@zna.be
Contact Person Name: Simon Van Wambeke
Contact Person Email: simon.vanwambeke@zna.be

Site Name: Institut Jules Bordet
Department Name: Medicine Oncology
Principal Investigator Name: Nieves Martinez Chanza
Principal Investigator Email: n.martinezchanza@hubruxelles.be
Contact Person Name: Nieves Martinez Chanza
Contact Person Email: n.martinezchanza@hubruxelles.be

Site Name: Algemeen Ziekenhuis Groeninge
Department Name: Urology
Principal Investigator Name: Eva Van Bos
Principal Investigator Email: eva.vanbos@azgroeninge.be
Contact Person Name: Eva Van Bos
Contact Person Email: eva.vanbos@azgroeninge.be

Site Name: Jessa Ziekenhuis
Principal Investigator Name: Daisy Luyten
Principal Investigator Email: Daisy.luyten@jessazh.be
Contact Person Name: Daisy Luyten
Contact Person Email: Daisy.luyten@jessazh.be

Site Name: Az Maria Middelares Gent
Department Name: Oncology
Principal Investigator Name: Christof Vulsteke
Principal Investigator Email: Christof.vulsteke@azmmsj.be
Contact Person Name: Christof Vulsteke
Contact Person Email: Christof.vulsteke@azmmsj.be

Site Name: UZ Leuven
Department Name: Oncologic, Robotic and Reconstructive Urology
Principal Investigator Name: Steven Joniau
Principal Investigator Email: steven.joniau@uzleuven.be
Contact Person Name: Steven Joniau
Contact Person Email: steven.joniau@uzleuven.be

Site Name: AZ Sint-Lucas & Volkskliniek
Department Name: Medical Oncology
Principal Investigator Name: Vincent Renard
Principal Investigator Email: vincent.renard@azstlucas.be
Contact Person Name: Vincent Renard
Contact Person Email: vincent.renard@azstlucas.be

Site Name: Azorg
Department Name: Urology
Principal Investigator Name: Edward Lambert
Principal Investigator Email: edward.lambert@azorg.be
Contact Person Name: Edward Lambert
Contact Person Email: edward.lambert@azorg.be

Site Name: Ziekenhuis Aan De Stroom (duplicate entry if present)

Czechia

Earliest CTIS Part Ii Submission Date: 26-11-2025
Latest Decision Or Authorization Date: 08-01-2026
Processing Time Days: 43
Number Of Sites: 8
Number Of Participants: 27

Sites

Site Name: Fakultni Thomayerova nemocnice
Department Name: Onkologicka klinika 1. LF UK
Principal Investigator Name: Eugen Kubala
Principal Investigator Email: eugen.kubala@ftn.cz
Contact Person Name: Eugen Kubala
Contact Person Email: eugen.kubala@ftn.cz

Site Name: Nemocnice AGEL Novy Jicin a.s.
Department Name: Oddeleni radioterapie a onkologie
Principal Investigator Name: David Vrana
Principal Investigator Email: studienovyjicin@yahoo.com
Contact Person Name: David Vrana
Contact Person Email: studienovyjicin@yahoo.com

Site Name: Fakultni Nemocnice V Motole
Department Name: Onkologicka klinika 2. LF UK a FN Motol
Principal Investigator Name: Tomas Buchler
Principal Investigator Email: tomas.buchler@fnmotol.cz
Contact Person Name: Tomas Buchler
Contact Person Email: tomas.buchler@fnmotol.cz

Site Name: Fakultni Nemocnice U Sv Anny V Brne
Department Name: Onkologicko-chirurgicke oddeleni
Principal Investigator Name: Jana Katolicka
Principal Investigator Email: jana.katolicka@fnusa.cz
Contact Person Name: Jana Katolicka
Contact Person Email: jana.katolicka@fnusa.cz

Site Name: University Hospital Olomouc
Department Name: Onkologicka klinika
Principal Investigator Name: Bohuslav Melichar
Principal Investigator Email: bohuslav.melichar@fnol.cz
Contact Person Name: Bohuslav Melichar
Contact Person Email: bohuslav.melichar@fnol.cz

Site Name: Masarykuv Onkologicky Ustav
Department Name: "Klinika komplexni onkologicke pece "
Principal Investigator Name: Stanislav Spelda
Principal Investigator Email: spelda@mou.cz
Contact Person Name: Stanislav Spelda
Contact Person Email: spelda@mou.cz

Site Name: Urocentrum Praha s.r.o.
Principal Investigator Name: Michaela Matouskova
Principal Investigator Email: matouskova@urocentrum.cz
Contact Person Name: Michaela Matouskova
Contact Person Email: matouskova@urocentrum.cz

Site Name: Fakultni Nemocnice Hradec Kralove
Department Name: Klinika onkologie a radioterapie
Principal Investigator Name: Miroslav Hodek
Principal Investigator Email: miroslav.hodek@fnhk.cz
Contact Person Name: Miroslav Hodek
Contact Person Email: miroslav.hodek@fnhk.cz

France

Earliest CTIS Part Ii Submission Date: 09-12-2025
Latest Decision Or Authorization Date: 09-01-2026
Processing Time Days: 31
Number Of Sites: 12
Number Of Participants: 60

Sites

Site Name: Clinique Pasteur Lanroze
Department Name: CFRO -Clinique Pasteur
Principal Investigator Name: Ali Hasbini
Principal Investigator Email: alihasbini@oncologie-brest.fr
Contact Person Name: Ali Hasbini
Contact Person Email: alihasbini@oncologie-brest.fr

Site Name: Institut De Cancerologie De L Ouest
Department Name: Oncology
Principal Investigator Name: Sophie Abadie-Lacourtoisie
Principal Investigator Email: Sophie.Abadie-Lacourtoisie@ico.unicancer.fr
Contact Person Name: Sophie Abadie-Lacourtoisie
Contact Person Email: Sophie.Abadie-Lacourtoisie@ico.unicancer.fr

Site Name: CHU Besancon
Department Name: Medical Oncology
Principal Investigator Name: Morgan Goujon
Principal Investigator Email: m1goujon@chu-besancon.fr
Contact Person Name: Morgan Goujon
Contact Person Email: m1goujon@chu-besancon.fr

Site Name: Institut Gustave Roussy
Principal Investigator Name: Alice Bernard-Tessier
Principal Investigator Email: alice.bernard-tessier@gustaveroussy.fr
Contact Person Name: Alice Bernard-Tessier
Contact Person Email: alice.bernard-tessier@gustaveroussy.fr

Site Name: Centre Hospitalier Departemental Vendee
Department Name: Onco-Hematology
Principal Investigator Name: Céline Bihan
Principal Investigator Email: celine.bihan@chd-vendee.fr
Contact Person Name: Céline Bihan
Contact Person Email: celine.bihan@chd-vendee.fr

Site Name: Centre Leon Berard
Department Name: Medical Oncology
Principal Investigator Name: Aude Flechon
Principal Investigator Email: aude.flechon@lyon.unicancer.fr
Contact Person Name: Aude Flechon
Contact Person Email: aude.flechon@lyon.unicancer.fr

Site Name: Centre Antoine Lacassagne
Principal Investigator Name: Delphine Borchiellini
Principal Investigator Email: DELPHINE.BORCHIELLINI@NICE.UNICANCER.FR
Contact Person Name: Delphine Borchiellini
Contact Person Email: DELPHINE.BORCHIELLINI@NICE.UNICANCER.FR

Site Name: Institut Bergonie
Principal Investigator Name: Guilhem Roubaud
Principal Investigator Email: g.roubaud@bordeaux.unicancer.fr
Contact Person Name: Guilhem Roubaud
Contact Person Email: g.roubaud@bordeaux.unicancer.fr

Site Name: Hospices Civils De Lyon
Department Name: Oncology
Principal Investigator Name: Denis Maillet
Principal Investigator Email: denis.maillet@chu-lyon.fr
Contact Person Name: Denis Maillet
Contact Person Email: denis.maillet@chu-lyon.fr

Site Name: Centre Hospitalier De La Cote Basque
Department Name: Medical Oncology
Principal Investigator Name: Louis Francois
Principal Investigator Email: lfrancois@ch-cotebasque.fr
Contact Person Name: Louis Francois
Contact Person Email: lfrancois@ch-cotebasque.fr

Site Name: Institut Godinot
Department Name: Clinical Research Unit
Principal Investigator Name: Jean-Christophe Eymard
Principal Investigator Email: jc.eymard@reims.unicancer.fr
Contact Person Name: Jean-Christophe Eymard
Contact Person Email: jc.eymard@reims.unicancer.fr

Site Name: Assistance Publique Hopitaux De Paris
Department Name: Medical Oncology
Principal Investigator Name: Alexandre Ingles
Principal Investigator Email: Alexandre.ingels@aphp.fr
Contact Person Name: Alexandre Ingles
Contact Person Email: Alexandre.ingels@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date: 03-12-2025
Latest Decision Or Authorization Date: 23-12-2025
Processing Time Days: 20
Number Of Sites: 12
Number Of Participants: 54

Sites

Site Name: Charite Universitaetsmedizin Berlin KöR
Principal Investigator Name: Maria De Santis
Principal Investigator Email: maria.de-santis@charite.de
Contact Person Name: Maria De Santis
Contact Person Email: maria.de-santis@charite.de

Site Name: Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Principal Investigator Name: Tilman Todenhöfer
Principal Investigator Email: todenhoefer@studienurologie.de
Contact Person Name: Tilman Todenhöfer
Contact Person Email: todenhoefer@studienurologie.de

Site Name: Universitaetsklinikum Schleswig-Holstein AöR
Department Name: Klinik fuer Urologie Campus Luebeck
Principal Investigator Name: Axel Merseburger
Principal Investigator Email: axel.merseburger@uksh.de
Contact Person Name: Axel Merseburger
Contact Person Email: axel.merseburger@uksh.de

Site Name: Universitaetsklinikum Regensburg AöR
Department Name: Caritas Krankenhaus St. Josef
Principal Investigator Name: Marco Schnabel
Principal Investigator Email: mschnabel@csj.de
Contact Person Name: Marco Schnabel
Contact Person Email: mschnabel@csj.de

Site Name: University Medical Center Hamburg-Eppendorf
Principal Investigator Name: Gunhild von Amsberg
Principal Investigator Email: g.von-amsberg@uke.de
Contact Person Name: Gunhild von Amsberg
Contact Person Email: g.von-amsberg@uke.de

Site Name: Universitaetsklinikum Ulm AöR
Principal Investigator Name: Friedemann Zengerling
Principal Investigator Email: friedemann.zengerling@uniklinik-ulm.de
Contact Person Name: Friedemann Zengerling
Contact Person Email: friedemann.zengerling@uniklinik-ulm.de

Site Name: Universitaetsmedizin Goettingen
Department Name: Klinik für Urologie
Principal Investigator Name: Arne Strauß
Principal Investigator Email: astrauss@med.uni-goettingen.de
Contact Person Name: Arne Strauß
Contact Person Email: astrauss@med.uni-goettingen.de

Site Name: Universitaetsklinikum Duesseldorf AöR
Principal Investigator Name: Guenter Niegisch
Principal Investigator Email: Guenter.Niegisch@med.uni-duesseldorf.de
Contact Person Name: Guenter Niegisch
Contact Person Email: Guenter.Niegisch@med.uni-duesseldorf.de

Site Name: Universitaetsklinikum Heidelberg AöR
Principal Investigator Name: Stefanie Zschäbitz
Principal Investigator Email: Stefanie.Zschaebitz@med.uni-heidelberg.de
Contact Person Name: Stefanie Zschäbitz
Contact Person Email: Stefanie.Zschaebitz@med.uni-heidelberg.de

Site Name: Urologie Neandertal
Principal Investigator Name: Philipp Spiegelhalder
Principal Investigator Email: mettmann@urologie-neandertal.de
Contact Person Name: Philipp Spiegelhalder
Contact Person Email: mettmann@urologie-neandertal.de

Site Name: Universitaetsklinikum Tuebingen AöR
Department Name: Klinik für Urologie
Principal Investigator Name: Eva Erne
Principal Investigator Email: Eva.Erne@med.uni-tuebingen.de
Contact Person Name: Eva Erne
Contact Person Email: Eva.Erne@med.uni-tuebingen.de

Site Name: Universitaet Muenster
Department Name: Klinik fuer Urologie
Principal Investigator Name: Martin Boegemann
Principal Investigator Email: martin.boegemann@ukmuenster.de
Contact Person Name: Martin Boegemann
Contact Person Email: martin.boegemann@ukmuenster.de

Spain

Earliest CTIS Part Ii Submission Date: 10-12-2025
Latest Decision Or Authorization Date: 02-01-2026
Processing Time Days: 23
Number Of Sites: 14
Number Of Participants: 63

Sites

Site Name: Hospital Universitario 12 De Octubre
Department Name: Oncology
Principal Investigator Name: Daniel Catellano Gauna
Principal Investigator Email: cdanicas@hotmail.com
Contact Person Name: Daniel Catellano Gauna
Contact Person Email: cdanicas@hotmail.com

Site Name: Hospital Clinic De Barcelona
Department Name: Oncology
Principal Investigator Name: Begoña Mellado Gonzalez
Principal Investigator Email: bmellado@clinic.cat
Contact Person Name: Begoña Mellado Gonzalez
Contact Person Email: bmellado@clinic.cat

Site Name: Hospital Universitario Virgen De La Victoria
Department Name: Oncology
Principal Investigator Name: Lucía Oliva Fernández
Principal Investigator Email: luciaolifer3@gmail.com
Contact Person Name: Lucía Oliva Fernández
Contact Person Email: luciaolifer3@gmail.com

Site Name: Institut Catala D'oncologia
Department Name: Oncology
Principal Investigator Name: Josep Maria Piulats Rodriguez
Principal Investigator Email: jmpiulats@iconcologia.net
Contact Person Name: Josep Maria Piulats Rodriguez
Contact Person Email: jmpiulats@iconcologia.net

Site Name: Hospital Alvaro Cunqueiro
Department Name: Oncology
Principal Investigator Name: Martin Emilio Lazaro Quintela
Principal Investigator Email: martin.lazaro.quintela@sergas.es
Contact Person Name: Martin Emilio Lazaro Quintela
Contact Person Email: martin.lazaro.quintela@sergas.es

Site Name: Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Department Name: Oncology
Principal Investigator Name: Mariona Figols Gorina
Principal Investigator Email: mfigols@althaia.cat
Contact Person Name: Mariona Figols Gorina
Contact Person Email: mfigols@althaia.cat

Site Name: Fundacion Instituto Valenciano De Oncologia
Department Name: Oncology
Principal Investigator Name: María José Juan Fita
Principal Investigator Email: mjuanfi81@hotmail.com
Contact Person Name: María José Juan Fita
Contact Person Email: mjuanfi81@hotmail.com

Site Name: Hospital Universitario Fundacion Jimenez Diaz
Department Name: Oncology
Principal Investigator Name: Imanol Martinez Salas
Principal Investigator Email: imanol.martinez@quironsalud.es
Contact Person Name: Imanol Martinez Salas
Contact Person Email: imanol.martinez@quironsalud.es

Site Name: Hospital Universitario Ramon Y Cajal
Department Name: Oncology
Principal Investigator Name: Teresa Alonso Gordoa
Principal Investigator Email: talonsogordoa@gmail.com
Contact Person Name: Teresa Alonso Gordoa
Contact Person Email: talonsogordoa@gmail.com

Site Name: Hospital Clinico San Carlos
Department Name: Oncology
Principal Investigator Name: Javier Puente Vazquez
Principal Investigator Email: javierpuente.hcsc@gmail.com
Contact Person Name: Javier Puente Vazquez
Contact Person Email: javierpuente.hcsc@gmail.com

Site Name: Hospital Del Mar
Department Name: Oncology
Principal Investigator Name: Alejo Rodríguez-Vida Rodríguez
Principal Investigator Email: arodriguezvida@parcdesalutmar.cat
Contact Person Name: Alejo Rodríguez-Vida Rodríguez
Contact Person Email: arodriguezvida@parcdesalutmar.cat

Site Name: Consorcio Hospital General Universitario De Valencia
Department Name: Oncology
Principal Investigator Name: Cristina Caballero Diaz
Principal Investigator Email: caballero_cri@gva.es
Contact Person Name: Cristina Caballero Diaz
Contact Person Email: caballero_cri@gva.es

Site Name: Hospital Universitario Virgen De La Victoria (duplicate / other contact)

Site Name: Hospital Universitario 12 De Octubre (duplicate / other contact)

Netherlands

Earliest CTIS Part Ii Submission Date: 10-12-2025
Latest Decision Or Authorization Date: 30-12-2025
Processing Time Days: 20
Number Of Sites: 4
Number Of Participants: 19

Sites

Site Name: Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Principal Investigator Name: Andre Bergman
Principal Investigator Email: A.BERGMAN@NKI.NL
Contact Person Name: Andre Bergman
Contact Person Email: A.BERGMAN@NKI.NL

Site Name: Canisius Wilhelmina Ziekenhuis
Principal Investigator Name: Diederik Somford
Principal Investigator Email: r.somford@cwz.nl
Contact Person Name: Diederik Somford
Contact Person Email: r.somford@cwz.nl

Site Name: Reinier de Graaf Groep
Principal Investigator Name: Addy Luijtgaarden
Principal Investigator Email: a.vandeluijtgaarden@rdgg.nl
Contact Person Name: Addy Luijtgaarden
Contact Person Email: a.vandeluijtgaarden@rdgg.nl

Site Name: Tergooiziekenhuizen
Principal Investigator Name: Pieter Van den Bergh
Principal Investigator Email: pvandenberg@tergooi.nl
Contact Person Name: Pieter Van den Bergh
Contact Person Email: pvandenberg@tergooi.nl

Poland

Earliest CTIS Part Ii Submission Date: 05-12-2025
Latest Decision Or Authorization Date: 04-01-2026
Processing Time Days: 30
Number Of Sites: 11
Number Of Participants: 38

Sites

Site Name: Zachodniopomorskie Centrum Onkologii
Department Name: Ośrodek Badań Klinicznych
Principal Investigator Name: Katarzyna Hetman
Principal Investigator Email: khetman@onkologia.szczecin.pl
Contact Person Name: Katarzyna Hetman
Contact Person Email: khetman@onkologia.szczecin.pl

Site Name: Szpitale Pomorskie Sp. z o.o.
Department Name: Oddział Onkologii i Radioterapii
Principal Investigator Name: Dorota Filarska
Principal Investigator Email: dfilarska@szpital-morski.pl
Contact Person Name: Dorota Filarska
Contact Person Email: dfilarska@szpital-morski.pl

Site Name: Polimed Clinic Sp. z o.o.
Principal Investigator Name: Krzysztof Tupikowski
Principal Investigator Email: tupikowski@poczta.onet.pl
Contact Person Name: Krzysztof Tupikowski
Contact Person Email: tupikowski@poczta.onet.pl

Site Name: Centrum Medyczne Medyk Sp. z o.o. S.K.
Principal Investigator Name: Kamil Kuć
Principal Investigator Email: kkuc@wszp.pl
Contact Person Name: Kamil Kuć
Contact Person Email: kkuc@wszp.pl

Site Name: Clinical Research Center Sp. z o.o. Medic-R sp.k.
Principal Investigator Name: Ilona Bar-Letkiewicz
Principal Investigator Email: ilona.bar-letkiewicz@cr-center.pl
Contact Person Name: Ilona Bar-Letkiewicz
Contact Person Email: ilona.bar-letkiewicz@cr-center.pl

Site Name: Clinical Best Solutions Sp. z o.o. S.K.
Principal Investigator Name: Paweł Płaza
Principal Investigator Email: pawel.plaza@gmail.com
Contact Person Name: Paweł Płaza
Contact Person Email: pawel.plaza@gmail.com

Site Name: Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name: Oddział Onkologii Klinicznej z Pododdziałem Dziennym
Principal Investigator Name: Anna Kowalczyk-Tekiela
Principal Investigator Email: atekiela@interia.pl
Contact Person Name: Anna Kowalczyk-Tekiela
Contact Person Email: atekiela@interia.pl

Site Name: EMC Instytut Medyczny S.A.
Principal Investigator Name: Rafał Kmieciak
Principal Investigator Email: raf.kmieciak@gmail.com
Contact Person Name: Rafał Kmieciak
Contact Person Email: raf.kmieciak@gmail.com

Site Name: Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name: Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Principal Investigator Name: Mariusz Kwiatkowski
Principal Investigator Email: mariusz.kwiatkowski@swk.med.pl
Contact Person Name: Mariusz Kwiatkowski
Contact Person Email: mariusz.kwiatkowski@swk.med.pl

Site Name: Other Polish sites (listed)

Site Name: Szpitale Pomorskie / additional entry

Slovakia

Earliest CTIS Part Ii Submission Date: 04-12-2025
Latest Decision Or Authorization Date: 22-12-2025
Processing Time Days: 18
Number Of Sites: 4
Number Of Participants: 16

Sites

Site Name: Privatna Urologicka Ambulancia s.r.o.
Department Name: Urology Department
Principal Investigator Name: Roman Sokol
Principal Investigator Email: roman.sokol@urology.sk
Contact Person Name: Roman Sokol
Contact Person Email: roman.sokol@urology.sk

Site Name: Milab s.r.o.
Department Name: Urology Department
Principal Investigator Name: Ivan Mincik
Principal Investigator Email: mincik.ivan@gmail.com
Contact Person Name: Ivan Mincik
Contact Person Email: mincik.ivan@gmail.com

Site Name: Vychodoslovensky Onkologicky Ustav a.s.
Department Name: Radiation Oncology Department
Principal Investigator Name: Pavol Dubinsky
Principal Investigator Email: dubinsky@vou.sk
Contact Person Name: Pavol Dubinsky
Contact Person Email: dubinsky@vou.sk

Site Name: Narodny Onkologicky Ustav
Department Name: II. Onkologická klinika LFUK a NOÚ
Principal Investigator Name: Michal Mego
Principal Investigator Email: michal.mego@nou.sk
Contact Person Name: Michal Mego
Contact Person Email: michal.mego@nou.sk

Bulgaria

Earliest CTIS Part Ii Submission Date: 11-12-2025
Latest Decision Or Authorization Date: 07-01-2026
Processing Time Days: 27
Number Of Sites: 3
Number Of Participants: 8

Sites

Site Name: Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Department Name: Department of Medical Oncology
Principal Investigator Name: Rossitza Ruseva
Principal Investigator Email: rossitza.krasteva@unihospitalbg.bg
Contact Person Name: Rossitza Ruseva
Contact Person Email: rossitza.krasteva@unihospitalbg.bg

Site Name: Complex Oncological Center Plovdiv EOOD
Department Name: First department of medical oncology and oncology diseases in gastroenterology
Principal Investigator Name: Antoaneta Tomova
Principal Investigator Email: dr.tomova@gmail.com
Contact Person Name: Antoaneta Tomova
Contact Person Email: dr.tomova@gmail.com

Site Name: Medical Centre Futuremeds EOOD
Principal Investigator Name: Nikolay Shopov
Principal Investigator Email: nikolay.shopov@futuremeds.bg
Contact Person Name: Nikolay Shopov
Contact Person Email: nikolay.shopov@futuremeds.bg

Greece

Earliest CTIS Part Ii Submission Date: 26-09-2025
Latest Decision Or Authorization Date: 13-02-2026
Processing Time Days: 140
Number Of Sites: 6
Number Of Participants: 23

Sites

Site Name: General Hospital Of Athens G Gennimatas
Department Name: 3rd Internal Medicine Clinic- Oncology Day Care Unit
Principal Investigator Name: Efthymios Kostouros
Principal Investigator Email: ekostouros@gmail.com
Contact Person Name: Efthymios Kostouros
Contact Person Email: ekostouros@gmail.com

Site Name: General Hospital Venizeleio-Pananeio
Department Name: Oncology Department
Principal Investigator Name: Nikolaos Androulakis
Principal Investigator Email: nandroulakis@yahoo.gr
Contact Person Name: Nikolaos Androulakis
Contact Person Email: nandroulakis@yahoo.gr

Site Name: Athens Medical Center S.A.
Department Name: 4th Department of Oncology
Principal Investigator Name: Ippokratis Korantzis
Principal Investigator Email: ippokratis.korantzis@gmail.com
Contact Person Name: Ippokratis Korantzis
Contact Person Email: ippokratis.korantzis@gmail.com

Site Name: University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name: 2nd Propaedeutic Dept of Internal Medicine
Principal Investigator Name: Aristotelis Bamias
Principal Investigator Email: abamias@med.uoa.gr
Contact Person Name: Aristotelis Bamias
Contact Person Email: abamias@med.uoa.gr

Site Name: Alexandra Hospital
Department Name: Oncology Department
Principal Investigator Name: Michalis Liontos
Principal Investigator Email: mliontos@gmail.com
Contact Person Name: Michalis Liontos
Contact Person Email: mliontos@gmail.com

Site Name: Metropolitan Hospital
Department Name: 2nd Oncology Department
Principal Investigator Name: Konstantinos Koutsoukos
Principal Investigator Email: koutsoukos.k@gmail.com
Contact Person Name: Konstantinos Koutsoukos
Contact Person Email: koutsoukos.k@gmail.com

Italy

Earliest CTIS Part Ii Submission Date: 26-09-2025
Latest Decision Or Authorization Date: 27-02-2026
Processing Time Days: 154
Number Of Sites: 13
Number Of Participants: 52

Sites

Site Name: Istituto Oncologico Veneto
Department Name: Oncologia Medica 1
Principal Investigator Name: Umberto Basso
Principal Investigator Email: umberto.basso@iov.veneto.it
Contact Person Name: Umberto Basso
Contact Person Email: umberto.basso@iov.veneto.it

Site Name: Azienda Ospedaliera Universitaria Integrata Verona
Department Name: Centro Ricerche Cliniche Di Verona
Principal Investigator Name: Andrea Zivi
Principal Investigator Email: andrea.zivi@aovr.veneto.it
Contact Person Name: Andrea Zivi
Contact Person Email: andrea.zivi@aovr.veneto.it

Site Name: I.F.O. Istituti Fisioterapici Ospitalieri
Department Name: Oncologia Medica 1
Principal Investigator Name: Fabio Calabrò
Principal Investigator Email: fabio.calabro@ifo.it
Contact Person Name: Fabio Calabrò
Contact Person Email: fabio.calabro@ifo.it

Site Name: Ospedale San Raffaele S.r.l.
Department Name: Department of Medical Oncology
Principal Investigator Name: Andrea Necchi
Principal Investigator Email: necchi.andrea@hsr.it
Contact Person Name: Andrea Necchi
Contact Person Email: necchi.andrea@hsr.it

Site Name: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name: Oncology Department
Principal Investigator Name: Giuseppe Schepisi
Principal Investigator Email: Giuseppe.schepisi@irst.emr.it
Contact Person Name: Giuseppe Schepisi
Contact Person Email: Giuseppe.schepisi@irst.emr.it

Site Name: Azienda Provinciale Per I Servizi Sanitari
Department Name: Medical Oncology
Principal Investigator Name: Orazio Caffo
Principal Investigator Email: orazio.caffo@apss.tn.it
Contact Person Name: Orazio Caffo
Contact Person Email: orazio.caffo@apss.tn.it

Site Name: Humanitas Mirasole S.p.A.
Department Name: Unit of Oncology and Hematology
Principal Investigator Name: Paolo Zucali
Principal Investigator Email: paolo.zucali@hunimed.eu
Contact Person Name: Paolo Zucali
Contact Person Email: paolo.zucali@hunimed.eu

Site Name: Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name: SCDU Oncologia Medica
Principal Investigator Name: Consuelo Buttigliero
Principal Investigator Email: consuelo.buttigliero@unito.it
Contact Person Name: Consuelo Buttigliero
Contact Person Email: consuelo.buttigliero@unito.it

Site Name: Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name: Oncologia Medica Ardizzoni
Principal Investigator Name: Francesco Massari
Principal Investigator Email: francesco.massari@aosp.bo.it
Contact Person Name: Francesco Massari
Contact Person Email: francesco.massari@aosp.bo.it

Site Name: Azienda Unita Sanitaria Locale Della Romagna
Department Name: Oncologia
Principal Investigator Name: Francesco Carrozza
Principal Investigator Email: francesco.carrozza@auslromagna.it
Contact Person Name: Francesco Carrozza
Contact Person Email: francesco.carrozza@auslromagna.it

Site Name: Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name: SCDU Oncologia
Principal Investigator Name: Alessia Mennitto
Principal Investigator Email: alessia.mennitto@maggioreosp.novara.it
Contact Person Name: Alessia Mennitto
Contact Person Email: alessia.mennitto@maggioreosp.novara.it

Site Name: Other Italian sites (listed)

Site Name: Istituto Oncologico Veneto (duplicate / other contact)

Finland

Earliest CTIS Part Ii Submission Date: 28-11-2025
Latest Decision Or Authorization Date: 11-05-2026
Processing Time Days: 164
Number Of Sites: 8
Number Of Participants: 34

Sites

Site Name: Vaasa Central Hospital
Department Name: Department of Clinical Oncology
Principal Investigator Name: Ravichandra Ravi
Principal Investigator Email: ravichandra.ravi@ovph.fi
Contact Person Name: Ravichandra Ravi
Contact Person Email: ravichandra.ravi@ovph.fi

Site Name: Tampere University Hospital
Department Name: Department of Urology
Principal Investigator Name: Teemu Murtola
Principal Investigator Email: teemu.murtola@pirha.fi
Contact Person Name: Teemu Murtola
Contact Person Email: teemu.murtola@pirha.fi

Site Name: Docrates Oy
Department Name: Docrates Cancer Center
Principal Investigator Name: Jorma Sormunen
Principal Investigator Email: jorma.sormunen@docrates.com
Contact Person Name: Jorma Sormunen
Contact Person Email: jorma.sormunen@docrates.com

Site Name: HUS-yhtymä
Principal Investigator Name: Antti Rannikko
Principal Investigator Email: antti.rannikko@hus.fi
Contact Person Name: Antti Rannikko
Contact Person Email: antti.rannikko@hus.fi

Site Name: Turku University Hospital
Principal Investigator Name: Peter Boström
Principal Investigator Email: peter.bostrom@varha.fi
Contact Person Name: Peter Boström
Contact Person Email: peter.bostrom@varha.fi

Site Name: Oulu University Hospital
Department Name: Department of Urology F3 (new department address is Kiviharjuntie 7)
Principal Investigator Name: Hanna Rönkainen
Principal Investigator Email: hanna.ronkainen@pohde.fi
Contact Person Name: Hanna Rönkainen
Contact Person Email: hanna.ronkainen@pohde.fi

Site Name: Kuopio University Hospital
Department Name: Syopatautien poliklinikka
Principal Investigator Name: Okko Kaariainen
Principal Investigator Email: okko.kaariainen@pshyvinvointialue.fi
Contact Person Name: Okko Kaariainen
Contact Person Email: okko.kaariainen@pshyvinvointialue.fi

Site Name: Additional Finnish site entry

Sponsor

Primary sponsor

Full Name: Pfizer Inc.
Organisation Type: Pharmaceutical company
Country Of Registered Address: United States

Contract research organisations

Name: Icon (Lr) Limited
Responsibilities: Training Portal

Name: PPD Global Clinical Labs

Name: IQVIA
Responsibilities: ePRO/eCOA

Third parties

{"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"Training Portal","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"PPD Global Clinical Labs","duties_or_roles":"","organisation_type":"Industry"}
{"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Investigator Reimbursements","organisation_type":"Non-Pharmaceutical company"}
{"country":"United States","full_name":"TecEx","duties_or_roles":"Importer of Record","organisation_type":"Industry"}
{"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Reimbursements","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"United States","full_name":"Clario","duties_or_roles":"Central Imaging","organisation_type":"Health care"}
{"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
{"country":"United States","full_name":"IQVIA","duties_or_roles":"ePRO/eCOA","organisation_type":"Health care"}

Investigational products

Investigational Product Name: PF-06821497
Active Substance: 5,8-DICHLORO-2-[(4-METHOXY-6-METHYL-2-OXO-1,2-DIHYDROPYRIDIN-3-YL)METHYL]-7-[(R)-METHOXY(OXETAN-3-YL)METHYL]-3,4-DIHYDROISOQUINOLIN-1(2H)-ONE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Maximum Dose: 1750 mg (product max daily dose amount as listed)

Investigational Product Name: Xtandi - 40 mg soft capsules
Active Substance: ENZALUTAMIDE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Marketing authorisation present (EU/1/13/846/001)
Maximum Dose: 160 mg (product max daily dose amount as listed)

Investigational Product Name: Tablet to match placebo for pf-06821497 125mg
Modality: Other

Investigational Product Name: Tablet to match placebo for pf-06821497 250mg
Modality: Other

Combination Treatment: Yes

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