|Principal Name||Harvey Zimbler, MD|
|Contact Name||Gloria Gero|
|Alternate Phone||(413) 443-6000|
|Title||CALGB 90203 " A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prosatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer"|
To determine whether treatment with neoadjuvant docetaxel and androgen deprivation therapy prior to radical prostatectomy will increase the rate of 3 year biochemical progression-free survial (bPFS) compared to treatment with immediate radical prostatectomy alone for high-risk prostate cancer patients.
Patient will be randomized toeither:
ARM A: LHRN agonist x 18 to 24 weeks
Docetaxel 75 mg/m2 every 21 days x 6 cycles
> followed by Surgical Intervention-a) Staging Pelvic lymphadenectomy
b) Radical prostatectommy
Staging pelvic lymphadenectomy
Chemohormonal therapy is to begin within 14 days of randomization. Surgery will take place within 60 days folloiwing the completion of neoadjuvant therapy for ARM A
Surgery is to take place within 60 days of randomization for ARM B
- Histologic documentaiton of protatic adenocarcinoma. Patients with small cell, neuroendocrine, or transitional cell
carcionomas are not eligible.
All eligible patients must have a known Gleason sum based on biopsy or TURP ast the time of registratoin.
- Patient must have clinical stage T1-3a and no radiographic evidence of metastatic disease as demonstrated by:
Either CT or MRI of abdomen and pelvis, OR endorectal MRI of the pelvis that demonstrate no nodes>1 cm.
Negative bone scan. Positive PET and Prostascint scans are not considered proof of metastatic disease.
- Patients must have either:
1) Kattan nomogram predicted probablity of being free from biochemical progression at 5 years after surgery of
2) Prostate biopsy Gleason sum>8
- No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection,
radiation therapy, or chemotherapy.
Patient may have received up to 4 months of androgen deprivation therapy (LHRH agonists, antiandrogrens, or
both) prior to being enrolled on the study.
- Patients must be appropriate candidates for radical prostataectomy with an estimated life expectancy >10 years as
determined by a uroloigst. Evidence of underlying cardiac disease should be evaluated prir to enrollment to ensure
that patieents are not at high risk of cardiac complications.
- Patients with a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or
currently requiring systemic anticoagulation are eligibile provided they are determiend to be candidates for radical
- ECOG PS: 0-2
- Age: >18 years of age
- Required Laboratory values:
Platelet count >150,000 u/L
Creatinine <2.0 mg/dL
Pre-registration serum PSA level <100 mg/mL
Bilirubin < upper limit of Institutional normal
AST/ALT <1.5 X ULN
|Current Trial Type||treatment|