C61 Malignant neoplasm of prostate Malignant neoplasm of prostate
Conditions
Interventions
None listed
Sponsors
Bayer Consumer Care AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed adenocarcinoma of prostate. - Documented metastatic disease by conventional imaging method either by a positive 99mTc-phosphonate bone scan, or soft tissue or visceral metastases, either by contrastenhanced abdominal/pelvic/chest CT or MRI scan assessed by central review. Note: Metastatic disease is defined as either malignant lesions in bone scan or measurable lymph nodes above the aortic bifurcation or soft tissue/visceral lesions according to RECIST version 1.1. Lymph nodes are measurable if the short axis diameter is =15 mm, soft tissue/visceral lesions are measurable if the long axis diameter is = 10 mm. Regional lymph node metastases only (N1, below the aortic bifurcation) will not be considered as metastases eligible for the study. Only participants with non-regional lymph node metastases (M1a) and/or bone metastases (M1b) and/or other sites of metastases with or without bone disease (M1c), assessed according to National Comprehensive Cancer Network (NCCN) classification, will be eligible. -Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti–androgen, but no longer than 12 weeks before randomization. For participants receiving LHRH agonists, treatment in combination with a first generation anti–androgen for at least 14 days prior to randomization is recommended.
Exclusion criteria
Exclusion criteria: 1. Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate. 2. Known brain/ leptomeningeal metastases Note: Brain CT/MRI scan should be performed only in case of symptoms. 3. Prior treatment with: - LHRH agonist/antagonists started = 12 weeks before study treatment starts except neoadjuvant and /or adjuvant therapy for a duration = 24 months and completed = 12 months prior to randomization - Second–generation androgen receptor (AR) inhibitors such as enzalutamide, darolutamide, apalutamide or other investigational AR inhibitors - Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer - Chemotherapy including docetaxel or immunotherapy for prostate cancer - Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days prior to randomization 4. Treatment with radiotherapy (external beam radiation therapy [EBRT], brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization. 7. Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization. 14. Inability to swallow oral medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| conventional imaging methods 99mTc-bone scan for bone metastases criteria and CT/MRI for soft tissue/visceral metastases NAME OF THE RESULT: •Radiological progression-free survival (rPFS) assessed by central review based on RECIST v. 1.1 criteria for soft tissue metastases and PCWG3 criteria for bone metastases PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: every 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| conventional imaging methods 99mTc-bone scan for bone metastases criteria and CT/MRI for soft tissue/visceral metastases NAME OF THE RESULT: •Radiological progression-free survival (rPFS) assessed by central review based on RECIST v. 1.1 criteria for soft tissue metastases and PCWG3 criteria for bone metastases PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: every 12 weeks;Clinic interviews / Review medical history NAME OF THE RESULT: Overall survival – key secondary endpoint PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: every 12 weeks;PSA values obtained by central laboratory NAME OF THE RESULT: Time to Castration-resistant prostate cancer PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: every 12 weeks;Clinic interviews NAME OF THE RESULT: Time to initiation of subsequent antineoplastic therapy PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: every 12 weeks;PSA values obtained by central laboratory NAME OF THE RESULT: Time to Prostate-specific antigen progression PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: every 12 weeks;PSA values obtained by central laboratory NAME OF THE RESULT: Prostate-specific antigen undetectable rates (<0.2 ng/mL) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: every 12 weeks;Brief Pain Inventory-Short Form NAME OF THE RESULT: Time to pain progression (Brief Pain Inventory-Short Form) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: every 12 weeks;Clinic interviews NAME OF THE RESULT: Adverse event assessments using National Cancer Institute–Common Terminology Criteria for Adverse Events (v.5.0) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCT | — |
Countries
Australia, Canada, Chile, China, Finland, India, Latvia, Lithuania, New Zealand, Russian Federation, South Africa, Spain, Taiwan, Ukraine
Outcome results
None listed