Active, not recruiting
Phase 2
Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer
Condition(s) studied
Stage IV Prostate Adenocarcinoma AJCC v7
Investigational drug(s) / intervention(s)
Antiandrogen TherapyDocetaxelLaboratory Biomarker AnalysisQuality-of-Life AssessmentQuestionnaire AdministrationRadical Prostatectomy
Antiandrogen Therapy: To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.
Docetaxel: To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
Radical Prostatectomy: Undergo cytoreductive radical prostatectomy
Study summary
This is a phase 2.5 international, multi-institution, randomized clinical trial to evaluate the potential therapeutic effect of CRP combined with the BST in men with mPCa prospectively. Such hybrid design permits the inclusion of the patients who have accrued to the phase 2 investigation to phase 3 trial, thereby decreasing the number of patients needed overall (5-7). In the initial phase 2 study, we plan to accrue 190 patients.
Eligibility
Inclusion Criteria:
* Histologically proven adenocarcinoma of the prostate
* Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
* Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis.
* If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET \[positron emission tomography\], bone scan and MRI, modality at the discretion of the treating physician)
* No previous local therapy for prostate cancer (i.e prostate radiation, cryotherapy, etc.)
* Give informed consent
* Prostate deemed resectable by surgeon
* Plans to start or has already started ADT no longer than 6 months prior to consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Hemoglobin (HgB) \>= 9 g/dL compatible for surgery
* Platelets \> 80,000/mcL compatible for surgery
* Aspartate aminotransferase (AST) =\< 2x upper limit of normal (ULN) compatible for surgery
* Alanine aminotransferase (ALT) =\< 2x upper limit of normal (ULN) compatible for surgery
Exclusion Criteria:
* Refuses to give informed consent
* Deemed to have unresectable disease by surgeon
* Received ADT for more than 6 months prior to consent
* Life expectancy of less than 6 months prior to consent
* Active spinal cord compression
* Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to consent
* Previous local therapy for prostate cancer
* Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent
Primary outcome measure(s)
- Failure-free survival (FFS) — At 2 years
Failure is defined as any one of the following events: PSA progression, clinical progression, radiographic progression, or death. The % of men who fail within 2 years of randomization will be compare between the two groups using a one-sided log-rank test.
Trial sites (16)
| Facility | City | Region | Status |
| City of Hope |
Duarte |
California |
|
| University of California, Irvine |
Irvine |
California |
|
| University of Southern California |
Los Angeles |
California |
|
| Yale University |
New Haven |
Connecticut |
|
| Rutgers Cancer Institute of New Jersey |
New Brunswick |
New Jersey |
|
| University of Pennsylvania |
Philadelphia |
Pennsylvania |
|
| Swedish Medical Services |
Seattle |
Washington |
|
| Epworth Healthcare |
East Melbourne |
Australia |
|
| Chinese University of Hong Kong |
Hong Kong |
China |
|
| Kindai University |
Ōsaka-sayama |
Osaka |
|
| Akita University |
Akita |
Japan |
|
| Juntendo University |
Tokyo |
Japan |
|
| National Cancer Center |
Goyang-si |
South Korea |
|
| Seoul National University Bundang Hospital |
Gyeonggi-do |
South Korea |
|
| Samsung Medical Center |
Seoul |
South Korea |
|
| National Taiwan University Hospital |
Taipei |
Taiwan |
|
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