Phase 3 study of oral drug, darolutamide in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC), that has spread to other parts of body (metastatic)

Phase 3

Conditions: Health Condition 1: C61- Malignant neoplasm of prostate

Registration Number: CTRI/2021/03/032172

Lead Sponsor: Bayer Consumer Care AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Written informed consent obtained.

2. Histologically or cytologically confirmed adenocarcinoma of prostate.

3. Documented metastatic disease.

4. Started androgen deprivation therapy (ADT) (luteinizing hormone releasing hormone [LHRH] agonist/antagonist or orchiectomy) with or without first generation anti–androgen, but no longer than 12 weeks before randomization.

5. First generation anti–androgen must be discontinued at least 1 day before study treatment start.

6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2.

7. Laboratory test values at screening meeting criteria per protocol.

Exclusion Criteria

1. Prior treatment with LHRH agonist/antagonists, second–generation androgen receptor (AR) inhibitors, cytochrome P 17 enzyme inhibitor or oral ketoconazole as antineoplastic treatment for prostate cancer, chemotherapy including docetaxel or immunotherapy for prostate cancer, use of systemic corticosteroid per protocol specified timelines and dosages, and prior to randomization where applicable.

2. Treatment with radiotherapy within 2 weeks before randomization.

3. Contraindication to iodinated computed tomography (CT) and gadolinium chelate magnetic resonance imaging (MRI) intravenous contrast agent(s).

4. Any prior malignancy within 5 years prior to randomization, as specified in the protocol.

5. 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).

6. Uncontrolled hypertension despite medical management.

7. A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug.

8. Inability to swallow oral medications.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiological progression-free survival (rPFS)Timepoint: Treatment: <br/ ><br>Visit 2 and subsequent visits (every 12 weeks) <br/ ><br> <br/ ><br>Follow-up (for participants who discontinue study drug without radiological disease progression): <br/ ><br>a. Active follow-up: End of treatment (EOT) visit and active follow-up visits (every 12 weeks from discontinuation of treatment for approximately 1 year) <br/ ><br>b. Long-term follow-up (every 12 weeks after Active follow–up)

Secondary Outcome Measures