Protocol Summary

Protocol No.: OCR15279

Sponsor Protocol No.: 17777; ARASENS

Study Title
A Randomized, Double-blind, Placebo Controlled Phase III Study of ODM-201 Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

Principal Investigator(s)
Dang, Long

The purpose of the study is to assess the efficacy and safety of BAY1841788 (ODM-201) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

This is a randomized, double-blind, placebo-controlled, multicenter phase III study. The study population will consist of approximately 1300 subjects with metastatic hormone sensitive prostate cancer (mHSPC), who will be randomized (1:1 ratio) to receive either ODM-201 600 mg (2 x 300 mg tablets) bid orally with food or placebo, in addition to standard androgen deprivation therapy (ADT) and docetaxel. Subjects will be stratified at randomization for the extent of disease and for Alkaline Phosphatase levels. All subjects will be treated with ADT as standard therapy. Six cycles of docetaxel will be administered after randomization.

The subjects considered for inclusion in the study will have metastatic prostate cancer and will be candidates for ADT and docetaxel.

Treatment with ODM-201/placebo will be administered until symptomatic progressive disease, change of antineoplastic therapy, unacceptable toxicity, until subject withdraws consent, withdrawal from the study at the discretion of the Investigator or his/her designated associate(s), death, non-compliance, or if Sponsor terminates the study.

Phase: Phase III (Cancer Control)

Age Group: Adult

Scope: National

BAY 1841788 / ODM-201 + standard ADT + Docetaxel:
BAY 1841788 / ODM-201 600 mg (2 x 300 mg tables) BID with food to a daily dose of 1200 mg in addition to standard ADT (luteinizing hormone releasing hormone (LHRH) agonist/antagonist or orchiectomy) and 6 cycles of docetaxel

Placebo + standard ADT + Docetaxel:
Placebo matching ODM-201 tablets in appearance, bid orally with food, in addition to standard ADT (luteinizing hormone releasing hormone [LHRH] agonist/antagonist or orchiectomy) and 6 cycles of docetaxel.

Detailed Eligibility
1. Ages 18 years old and older
2. Histologically or cytologically confirmed adenocarcinoma of prostate.
3. Metastatic disease
4. Candidates for ADT and docetaxel. Started ADT with or without first generation anti androgen, but no longer than 12 weeks before randomization
5. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate bone marrow, liver and renal function

1. Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, ODM-201; other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer, chemotherapy or immunotherapy for prostate cancer prior to randomization.
2. Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.
3. Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
4. Had a 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 treatment has been completed 5 years before randomization and from which the subject has been disease-free
5. Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment.
6. Inability to swallow oral medications

Applicable Disease Sites
Prostate Cancer

Participating Institutions
UF Gainesville : Sherri Mizrahy

Sherri Mizrahy, RN, MSN, CPON
Phone: +1 352-265-0702


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