A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer
- Conditions
- 10038597metastatic prostate cancer
- Registration Number
- NL-OMON38355
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 35
4. Histologically or cytologically confirmed adenocarcinoma of the prostate
5. Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI. If lymph node metastasis is the only evidence of metastasis, it must be >= 2 cm in diameter
6. Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria
7. Asymptomatic or mildly symptomatic from prostate cancer. A score of 0-1 on BPI-SF Question #3 (worst pain in last 24 hours) will be considered asymptomatic, and a score of 2-3 will be considered mildly symptomatic.
8. Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM). If the patient is being treated with LHRH agonists (patient who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study.
9. Previous anti-androgen therapy and progression after withdrawal. Patients who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (>= 4 weeks since last flutamide,>= 6 weeks since last bicalutamide or nilutamide).
10. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
1. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
2. Any chronic medical condition requiring a higher dose of corticosteroid than 5mg
prednisone/prednisolone bid.
3. Pathological finding consistent with small cell carcinoma of the prostate
4. Liver or visceral organ metastasis
5. Known brain metastasis
6. Use of opiate analgesics for cancer-related pain, including codeine and
dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
7. Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
8. Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day 1
9. Radiation or radionuclide therapy for treatment of metastatic CRPC
10. Previously treated with ketoconazole for prostate cancer for greater than 7 days
11. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
12. Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1)
13. Bicalutamide (Casodex), nilutamide (andron) within 6 weeks of Cycle 1 Day 1
(patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy Assessment:<br /><br>The primary efficacy endpoints are Overall Survival (OS) and Radiographic<br /><br>Progression-Free Survival (rPFS) (co-primary).<br /><br>• Efficacy assessment in rPFS will utilize sequential imaging studies as<br /><br>defined by PCWG2 and modified RECIST criteria.<br /><br>• Survival data will be collected throughout the study treatment phase and<br /><br>during follow-up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy assessments:<br /><br>• Time to opiate use for cancer-related pain and time to administration of<br /><br>cytotoxic chemotherapy for metastatic prostate cancer will be prospectively<br /><br>assessed.<br /><br>• ECOG performance status will be evaluated throughout the study to assess time<br /><br>to first deterioration.<br /><br>• PSA values will be collected throughout the study to assess time to PSA<br /><br>progression.<br /><br><br /><br>Other study endpoints:<br /><br>• PSA response rate [Proportion of patients achieving a PSA decline >= 50%<br /><br>according to Prostate Cancer Working Group (PCWG2) criteria].<br /><br>• Objective response rate in patients with measurable disease (RECIST).<br /><br>• Duration of response in patients with measurable disease.<br /><br>• QoL total score and each subscale score as assessed by FACT-P.<br /><br>• Time to pain progression.<br /><br>• Time to analgesic progression.</p><br>