Status:
ACTIVE_NOT_RECRUITING
Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause t...
Detailed Description
This randomized trial tests whether the addition of chemohormonal therapy improves PSA-progression free survival in patients with high risk, clinically-localized prostate cancer. The neoadjuvant appro...
Eligibility Criteria
Inclusion
- Histologic documentation - Histologic documentation of prostatic adenocarcinoma.
- Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible.
- All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration.
- Clinically localized disease - Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by:
- EITHER CT or MRI of the abdomen and pelvis, OR endorectal MRI of the pelvis that demonstrate no nodes \> 1.5 cm. If one or more pelvic lymph node(s) measures \> 1.5 cm, a negative biopsy is required. If more than one lymph node is \> 1.5 cm, the largest or most accessible node should be biopsied.
- AND
- Negative bone scan (with plain films and/or MRI and/or CT scan confirmation, if necessary). Positive PET and Prostascint scans are not considered proof of metastatic disease.
- Determination of high-risk status: Patients must have either:
- A Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of \< 60%.
- OR
- Prostate biopsy Gleason sum ≥ 8 (NOTE: The Kattan nomogram probability must be calculated for all patients, including those eligible based on Gleason sum ≥ 8 only.)
- Prior treatment - No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy.
- Patients may have received up to 4 months of androgen deprivation therapy (LHRH agonists, antiandrogens, or both) prior to being enrolled on the study.
- Appropriate surgical candidates - Patients must be appropriate candidates for radical prostatectomy with an estimated life expectancy \> 10 years as determined by a urologist. Evidence of underlying cardiac disease should be evaluated prior to enrollment to ensure that patients are not at high risk of cardiac complications.
- Clotting history - Patients with a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation are eligible provided they are determined to be candidates for radical prostatectomy.
- ECOG performance status: 0-2
- Age: ≥ 18 years of age
- Required Initial Laboratory Values:
- ANC ≥ 1500/μL
- Platelet count ≥ 150,000/μL
- Creatinine ≤ 2.0 mg/dL
- Pre-registration serum PSA level ≤ 100 ng/mL
- Bilirubin ≤ 1.5XULN (2.5XULN in patients with Gilbert's disease)
- AST/ALT ≤1.5XULN
Exclusion
Key Trial Info
Start Date :
May 8 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2030
Estimated Enrollment :
788 Patients enrolled
Trial Details
Trial ID
NCT00430183
Start Date
May 8 2007
End Date
October 1 2030
Last Update
February 9 2023
Active Locations (226)
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1
Providence Cancer Center
Anchorage, Alaska, United States, 99508
2
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
3
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
4
Peninsula Medical Center
Burlingame, California, United States, 94010