Clinical trial • Phase IV • Oncology

BICALUTAMIDE for Unfavorable intermediate-risk prostate cancer | High-risk prostate cancer

Phase IV trial of BICALUTAMIDE for Unfavorable intermediate-risk prostate cancer | High-risk prostate cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Unfavorable intermediate-risk prostate cancer | High-risk prostate cancer
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-02-2024
First CTIS Authorization Date
29-04-2024

Trial design

Randomised, sbrt with short-term androgen deprivation versus sbrt without androgen deprivation. androgen deprivation product listed: bicalutamide (product bicalutamide, max daily dose 50.00 g, route: buccal use) — specific dosing schedule in the trial is not specified in the available data.-controlled Phase IV trial across 3 sites in Italy.

Randomised
Yes
Comparator
SBRT with short-term androgen deprivation versus SBRT without androgen deprivation. Androgen deprivation product listed: BICALUTAMIDE (product BICALUTAMIDE, max daily dose 50.00 g, route: BUCCAL USE) — specific dosing schedule in the trial is not specified in the available data.
Target Sample Size
146
Trial Duration For Participant
1095

Eligibility

Recruits 146 No vulnerable population selected; trial population comprises adult male patients. Informed consent is required (subject information and informed consent form document is listed). No assent or specific vulnerable-population consent arrangements are described in the available data..

Vulnerable Population
No vulnerable population selected; trial population comprises adult male patients. Informed consent is required (subject information and informed consent form document is listed). No assent or specific vulnerable-population consent arrangements are described in the available data.

Inclusion criteria

  • {"criterion_text":"- Histologically proven prostate adenocarcinoma\n- IR or HR in the NCCN definition\n- N0M0 at staging with choline or (preferably) PSMA PET-CT;\n- ECOG performance status between 0 and 2;"}

Exclusion criteria

  • {"criterion_text":"- T3b disease according to the 8th AJCC classification;\n- PSA>20 ng/ml at any time point\n- Gleason Score of 9 or 10 (Grade Grouping V)\n- Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy)\n- Previous radiotherapy to the pelvis\n- Previous chemotherapy for malignancy in past 5 years\n- Impossibility to implant fiducials for tracking purposes\n- Impossibility to undergo MRI of the prostate\n- Contraindication to short term AD\n- Prostate volume >90cc"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary objective of the study is 3-yr bNED survival.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS) at 3 years\n- Prostate positive biopsy rates at 2 yrs\n- Metastases free survival at 3 yrs\n- Cumulative incidence of either GI/GU toxicity at 3 yrs (CTCAE v4.0)\n- Nadir PSA at various time points\n- Quality of Life at various time points (EORTC QLQ-C30 & FACT-P)\n- Erectile function at various time points (IIF-5)\n- Urinary Continence at various time points (ICIQ-Sf)\n- IPSS at various time points\n- Patient satisfaction with treatment at 3 yrs (FACIT-TS-G)","definition_or_measurement_approach":"Where specified in the protocol summary: GI/GU toxicity measured using CTCAE v4.0; Quality of Life measured using EORTC QLQ-C30 & FACT-P; Erectile function using IIF-5; Urinary continence using ICIQ-Sf; Patient satisfaction using FACIT-TS-G. Other endpoints are listed without additional measurement detail in the available data."}

Recruitment

Planned Sample Size
146
Recruitment Window Months
60
Consent Approach
Informed consent is required from participants; a subject information and informed consent form document is listed in the trial documents. No further details on age-specific consent/assent or languages are provided in the available data.

Geography

Total Number Of Sites
3
Total Number Of Participants
146

Italy

Latest Decision Or Authorization Date
25-10-2024
Number Of Sites
3
Number Of Participants
146

Sites

Site Name
Azienda Unita Locale Socio Sanitaria N. 1 Dolomiti
Department Name
Department of Radiation Oncology
Contact Person Name
Alessandro Magli
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Radiotherapy Unit
Contact Person Name
Giuseppe Sanguineti
Contact Person Email
giuseppe.sanguineti@ifo.it
Site Name
San Raffaele Hospital
Department Name
Radiotherapy Unit
Contact Person Name
Nadia Gisella Di Muzio
Contact Person Email
dimuzio.nadia@hsr.it

Sponsor

Primary sponsor

Full Name
I.F.O. Istituti Fisioterapici Ospitalieri
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
BICALUTAMIDE
Active Substance
BICALUTAMIDE
Modality
Small molecule
Routes Of Administration
BUCCAL USE
Route
BUCCAL USE
Authorisation Status
Authorised
Maximum Dose
50.00 g
Combination Treatment
Yes

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