Status:
TERMINATED
Post-operative or Early Salvage XRT and ADT for High Risk PCa
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Prostate Cancer
Eligibility:
MALE
Up to 80 years
Phase:
PHASE3
Brief Summary
RATIONALE: Conformal radiation therapy uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor. Giving conformal external-beam radiation therapy in hi...
Detailed Description
OBJECTIVES: * To investigate the potential benefit of post-operative radiotherapy with vs without a combined and adjuvant treatment consisting of short-term androgen suppression for improving the bio...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of prostate cancer
- Clinical stage cT1-2-3a, N0, M0 disease pre-operatively
- Pre-operative PSA ≤ 5 x upper limit of normal
- Presenting the following conditions after radical prostatectomy:
- Gleason sum 5-10
- Pathologic stage pT2R1 (positive surgical margins with at least a tumor trans-section \> 2 mm) or pT3a-b (irrespective of margin status)
- Negative lymph node (LN) status (pN0) by LN sampling or LN dissection
- Unknown pathological LN status is not allowed, except for disease classified as cT ≤ cT1c with baseline PSA ≤ 10 ng/mL, Gleason score \< 7, and ≥ 12 positive core biopsies \< 50%
- Undetectable post-operative PSA within 3 months of surgery
- PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- WBC ≥ 3 x 10\^9/L
- Hemoglobin ≥ 110 g/L
- Platelet count ≥ 100 x 10\^9/L
- No other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease free for at least 5 years
- No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 5 years since prior chemotherapy
- No prior pelvic irradiation
- No prior bilateral orchiectomy
- No prior hormonal treatment except neoadjuvant treatment lasting ≤ 3 months
- No other concurrent anticancer agent or modality
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00949962
Start Date
October 1 2009
End Date
June 1 2016
Last Update
July 4 2014
Active Locations (1)
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1
European Organization for Research and Treatment of Cancer
Grenoble, France, 38043