Status:
UNKNOWN
A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
ARTIC group (oncologists and urologists association)
Conditions:
Adenocarcinoma of the Prostate
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The primary objective was to evaluate the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel ...
Detailed Description
Docetaxel was shown to be active in metastatic hormone-refractory prostate cancer (PC) in phase III trials (1-2). It is likely to demonstrate a substantial role in the management of early-stage PC pat...
Eligibility Criteria
Inclusion
- Histologically documented adenocarcinoma of the prostate
- Previous treatment with either radical prostatectomy or radiation therapy
- Salvage radiotherapy for local relapse allowed
- Neoadjuvant or per radiotherapy Hormonal therapy allowed in case of more than 6 months free-interval before first rising PSA
- Life expectancy of more than 12 months
- Non metastatic disease documented by imaging including radionuclide bone scan
- ECOG performance status 0-1
- ANC \> 1,500/mm3
- Platelet counts \> 100,000/mm3
- SGOT and/or SGPT may be up to 2.5 x ULN
- Patients at high risk of biological relapse defined by:
- Gleason \> 8
- PSA-DT \< 6 months
- Positive surgical margins
- PSA velocity \> 0.75 ng/mL/year
- Pathological pelvic lymph nodes involvement (pN+)
- Time from initial treatment until inclusion \< 12 months
Exclusion
- Prior chemotherapy by taxanes and estramustine phosphate
- Documented local recurrence of prostate cancer or documented metastatic disease
- History of other malignancy within the last 5 years other than curatively treated basal cell carcinoma of the skin
- Active infection
- Significant cardiac disease, angina pectoris or myocardial infarction within twelve months
- Clinically significant neuropathy
- Medical condition requiring the use of concomitant corticosteroids
- Prohibited concomitant therapy with experimental drug.
- Participation in another clinical trial for the period \< 30 days
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00764166
Start Date
June 1 2003
End Date
November 1 2010
Last Update
October 1 2008
Active Locations (1)
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1
Service Oncologie Médicale, Hopital Europeen Georges Pompidou
Paris, France, 75015