ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer

NCT02972060 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: EORTC-15322016-004334-17
• Study Type: interventional
• Target: 61
• Locations: 4 countries
• Sites: 12

Brief Summary

This is an open label non-comparative controlled randomized phase II study. The experimental arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT) is included as an internal control. The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in the range of those achieved with 24 weeks of ADT. In total, this 1:1 randomized study will therefore require randomization of at least 250 patients, 125 to each arm.

Conditions

Prostate Cancer

Keywords

Hormone Naive Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• PSA response

  PSA response is defined as a ≥ 80% decline in PSA measurement taken at week 24 relative to the measurement taken at baseline, in the ODM-201 study arm. The ADT arm is used as an internal control.

  24 weeks

Secondary Outcomes (4)

• EORTC QLQ-PR25

  24 weeks

• Objective tumor response

  24 weeks

• 90% PSA response rate

  24 weeks

• evaluation of safety

  The collection period will start from randomization until 30 days after last protocol treatment administration.

Study Arms (2)

ADT

ACTIVE COMPARATOR

The standard treatment for this stage of the disease is ADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare. This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician.

Drug: ADT

ODM 201

EXPERIMENTAL

ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) bid for a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food. Subjects who have clinical benefit at week 24 may continue to receive ODM-201 at the discretion of the investigator until disease progression, objective or clinical, or occurrence of an unacceptable toxicity. This includes those that will receive external beam radiation therapy. Any anti-cancer therapy other than the study drug given as single agent will not be considered part of the protocol treatment.

Drug: ODM-201

Interventions

ODM-201 DRUG

ODM-201 is a novel, oral, potent nonsteroidal AR inhibitor. ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) b.i.d. to a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food. Treatment should be initiated within 28 days from randomization.

ODM 201

ADT DRUG

ADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare. This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician.

ADT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed prostate cancer (all stages) for whom continuous androgen-deprivation therapy (ADT) is indicated for a minimum period of 24 weeks
• Patient presenting with a maximum of 4 confirmed metastatic lesions, including bone, extra-pelvic lymph nodes, and pelvic lymph nodes \> 2 cm on baseline Computed tomography(CT) or Magnetic resonance imaging (MRI) and/or Tc bone scintigraphy. Visceral metastases are excluded
• Asymptomatic for metastatic prostate cancer; urinary symptoms are allowed
• Baseline testosterone ≥ 8 nmol/L or 230 ng/dL
• Two subsequent PSA values ≥ 2 ng/ml, taken at minimum 2-week interval, with the second being equal to or higher than the first one
• WHO performance status (PS) of 0-1
• G8 score ≥ 14 for patients aged ≥ 70 years old
• A life expectancy of at least 12 months
• Able to swallow the study drug and comply with the study requirements
• Adequate bone marrow function (absolute neutrophil count (ANC) ≥ 1.5 10exp9/L; hemoglobin ≥ 10.0 g/dl, platelets ≥ 100 10exp9/L)
• Adequate renal function: creatinine clearance/eGFR within normal limits to baseline assessed as per local standard method
• Albumin \> 25 g/L
• Adequate hepatic function:
• Bilirubin: total bilirubin ≤ to 1.5 X upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and/or Alanine aminotransferase(ALT) ≤ 2.5 X ULN

You may not qualify if:

• any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Previously or currently receiving hormonal therapy with intent to treat prostate cancer disease (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, anti-androgens, oestrogens, 5α-reductase inhibitor). For patients that have received (neo)adjuvant ADT before radiotherapy, it should have been stopped for more than 1 year
• Prior use of investigational agents that block androgen synthesis or block androgen receptor
• Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto)
• Has received systemic glucocorticoids within 24 weeks prior to enrollment or is expected to require systemic glucocorticoids during the study period
• Radiation therapy for treatment of the primary tumor within 3 months prior to enrollment
• Use of an investigational agent within 4 weeks prior to enrollment is not allowed. The maximum allowed duration may be extended to comply with national regulations in the participating countries.
• Gastrointestinal disorder affecting absorption (e.g. gastrectomy, active peptic ulcer disease within 3 months prior to enrollment)
• Known hypersensitivity to the study treatment or any of its ingredients (refer to Investigator's brochure).
• Severe or uncontrolled concurrent disease, infection or co-morbidity including active viral hepatitis, known human immunodeficiency virus infection with detectable viral load (Human immunodeficiency virus (HIV)) or chronic liver disease
• History of prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e. pTis, pTa, and pT1) is allowed, as well as any other cancer for which chemotherapy has been completed ≤ 5 years ago and from which the patient has been disease-free.
• Clinically significant cardiovascular disease including:
• Myocardial infarction within six months prior to randomization
• Uncontrolled angina within 3 months prior to randomization
• Coronary/peripheral artery bypass within 6 months prior to randomization

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Bayer: collaborator

Study Sites (12)

Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

CHU Dinant Godinne - UCL Namur

Yvoir, 5530, Belgium

Location

CHU de Dijon - Centre Georges-Francois-Leclerc

Dijon, 21079, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Ospedale Molinette

Torino, 10126, Italy

Location

Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Virgen De La Victoria

Málaga, 29010, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Fundacion Instituto Valenciano De Oncologia

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

darolutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bertrand Tombal, Pr

  Cliniques universitaires saint-Luc (Brussels)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 23, 2016
• Study Start: December 1, 2017
• Primary Completion: January 13, 2023
• Study Completion (Estimated): December 1, 2036
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4); FR (2); ES (5); IT (1)