Clinical trial • Phase III • Oncology
Apalutamide for Metastatic hormone-sensitive prostate cancer
Phase III trial of Apalutamide for Metastatic hormone-sensitive prostate cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic hormone-sensitive prostate cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 12-01-2024
- First CTIS Authorization Date
- 01-03-2024
Trial design
Randomised, apalutamide (jnj-56021927) oral film-coated tablet (max daily dose reported 240 mg) + androgen deprivation therapy (gonadotropin releasing hormone analogue, subcutaneous) versus androgen deprivation therapy alone with matching apalutamide placebo-controlled Phase III trial across 6 sites in Czechia, Romania, Spain.
- Randomised
- Yes
- Comparator
- Apalutamide (JNJ-56021927) oral film-coated tablet (max daily dose reported 240 mg) + androgen deprivation therapy (gonadotropin releasing hormone analogue, subcutaneous) versus androgen deprivation therapy alone with matching Apalutamide placebo
- Target Sample Size
- 122
Eligibility
Recruits 122 adults.
Inclusion criteria
- {"criterion_text":"- Diagnosis of prostate adenocarcinoma as confirmed by the investigator\n- Metastatic disease documented by greater than or equal to (>=) 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)\n- Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1\n- Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel <=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization\n- Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (<=) 6 months of ADT prior to randomization\n- Allowed prior treatments for localized prostate cancer (all treatments must have been completed >= 1 year prior to randomization) a) <= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy, lymph node dissection and systemic therapies"}
Exclusion criteria
- {"criterion_text":"- Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate\n- Known brain metastases\n- Lymph nodes as only sites of metastases\n- Visceral (ie, liver or lung) metastases as only sites of metastases\n- Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or noninvasive superficial bladder cancer\n- Prior treatment with other next generation antiandrogens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer\n- History of seizures or medications known to lower seizure threshold"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Radiographic Progression-Free Survival (rPFS)\n- Overall Survival (OS)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Time to Pain Progression\n- Time to Skeletal-Related Event (SRE)\n- Time to Chronic Opioid Use\n- Time to Initiation of Cytotoxic Chemotherapy","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 122
- Recruitment Window Months
- 133
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 7
Czechia
- Earliest CTIS Part Ii Submission Date
- 02-02-2024
- Latest Decision Or Authorization Date
- 08-08-2024
- Processing Time Days
- 188
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Nemocnice AGEL Novy Jicin a.s.
- Department Name
- Oddělení radioterapie a onkologie
- Contact Person Name
- Markéta Lavrišinová
- Contact Person Email
- marketa.lavrisinova@nnj.agel.cz
- Site Name
- Krajska nemocnice Liberec a.s.
- Department Name
- Urology
- Contact Person Name
- Vladimír Šámal
- Contact Person Email
- Vladimir.samal@nemlib.cz
Romania
- Earliest CTIS Part Ii Submission Date
- 02-02-2024
- Latest Decision Or Authorization Date
- 12-08-2024
- Processing Time Days
- 192
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Spitalul Clinic Prof.Dr.Theodor Burghele
- Department Name
- Urologie III
- Contact Person Name
- Viorel Jinga
- Contact Person Email
- vioreljinga@yahoo.com
- Site Name
- Oncolab S.R.L.
- Department Name
- Departamentul de cercetare - Oncolab
- Contact Person Name
- Dan Stelian Stefan Lungulescu
- Contact Person Email
- Oncolabcercetare@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 02-02-2024
- Latest Decision Or Authorization Date
- 09-08-2024
- Processing Time Days
- 189
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- CIOCC, Ensayos Clínicos planta S-1
- Contact Person Name
- Jesús García-Donas Jiménez
- Contact Person Email
- jgarciadonas@hmhospitales.com
- Site Name
- Hospital General Universitario Reina Sofia
- Department Name
- Urología
- Contact Person Name
- Francisco Anglada Curado
- Contact Person Email
- urologia.hrs.sspa@juntadeandalucia.es
Sponsor
Primary sponsor
- Full Name
- Janssen Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Almac Clinical Services Limited
- Responsibilities
- IP Returns and destruction
- Name
- Icon Clinical Research Limited
- Responsibilities
- code:5
Third parties
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"IP Returns and destruction (code:15)","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"subject reimbursement for travel and other visit expenses for Czech republic only (code:15)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- JNJ-56021927
- Active Substance
- Apalutamide
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorisation information present (prodAuthStatus:1)
- Maximum Dose
- 240 mg (maxDailyDoseAmount: 240)
- Investigational Product Name
- Apalutamide placebo
- Modality
- Other
- Investigational Product Name
- Androgen deprivation therapy (auxiliary product)
- Active Substance
- Gonadotropin releasing hormone analogues (e.g., leuprolide)
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- TULMIMETOSTAT for Metastatic hormone-sensitive prostate cancer
- LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN for Metastatic hormone-sensitive prostate cancer
- REZVILUTAMIDE for Metastatic hormone-sensitive prostate cancer
- LUXDEGALUTAMIDE for Metastatic hormone-sensitive prostate cancer
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer