Back to resultsPost-operative or Early Salvage XRT and ADT for High Risk PCa
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
antiandrogen therapy
leuprolide acetate
3-dimensional conformal radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
Eligibility Criteria
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
Sites / Locations
- European Organization for Research and Treatment of Cancer
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm I
Arm II
Arm Description
Patients undergo post-operative conformal external beam irradiation for 6.5 weeks.
Beginning on day -5 to -3, patients receive an antiandrogen for 2-4 weeks. Beginning on day 0, patients receive leuprolide acetate subcutaneously once (6-month depot) and undergo conformal external beam irradiation 5 times weekly for 6.5 weeks.
Outcomes
Primary Outcome Measures
Biochemical progression-free survival
Secondary Outcome Measures
Clinical progression-free survival
Distant-metastases-free survival
Overall survival
Quality of life as assessed by QLQ-C30 and QLQ-PR25 at baseline and at 6 months, 1 year, 2 years, and 5 years after treatment
Acute and late toxicity according to NCI CTCAE version 3.0
Full Information
NCT ID
NCT00949962
First Posted
July 30, 2009
Last Updated
July 3, 2014
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
1. Study Identification
Unique Protocol Identification Number
NCT00949962
Brief Title
Post-operative or Early Salvage XRT and ADT for High Risk PCa
Official Title
Immediate or Early Salvage Post-operative External Radiotherapy Combined With Concomitant and Adjuvant Hormonal Treatment Versus Immediate or Early Salvage Postoperative External Radiotherapy Alone in pT3a-b R0-1 cN0M0 / pT2R1 cN0M0, Gleason Score 5-10 Prostatic Carcinoma. A Phase III Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
Poorly recruiting
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as leuprolide acetate, may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective when given together with or without hormone therapy in treating patients with prostate cancer who have undergone surgery.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with hormone therapy in treating patients who have undergone surgery for stage I, stage II, or stage III prostate cancer.
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 biochemical progression-free survival of patients who have undergone radical prostatectomy for stage I-III prostate cancer.
OUTLINE: This is a multicenter study. Patients are stratified according to institution, pathological stage (pT2R1 vs pT3R0 vs pT3R1), Gleason sum (≤ 3+4 vs ≥ 4+3), and WHO performance status (0 vs 1). Within 3 months after radical surgery, patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo post-operative conformal external beam irradiation for 6.5 weeks.
Arm II: Beginning between days -5 to -3, patients receive an antiandrogen for 2-4 weeks. Beginning on day 0, patients receive leuprolide acetate subcutaneously once (6-month depot) and undergo conformal external beam irradiation 5 times weekly for 6.5 weeks.
Patients undergo quality of life assessments periodically.
After completion of study treatment, patients are followed up every 6 months for 5 years and then yearly thereafter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
Patients undergo post-operative conformal external beam irradiation for 6.5 weeks.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Beginning on day -5 to -3, patients receive an antiandrogen for 2-4 weeks. Beginning on day 0, patients receive leuprolide acetate subcutaneously once (6-month depot) and undergo conformal external beam irradiation 5 times weekly for 6.5 weeks.
Intervention Type
Drug
Intervention Name(s)
antiandrogen therapy
Intervention Description
Given systemically
Intervention Type
Drug
Intervention Name(s)
leuprolide acetate
Intervention Description
Given subcutaneously
Intervention Type
Radiation
Intervention Name(s)
3-dimensional conformal radiation therapy
Intervention Description
Undergo radiotherapy
Primary Outcome Measure Information:
Title
Biochemical progression-free survival
Secondary Outcome Measure Information:
Title
Clinical progression-free survival
Title
Distant-metastases-free survival
Title
Overall survival
Title
Quality of life as assessed by QLQ-C30 and QLQ-PR25 at baseline and at 6 months, 1 year, 2 years, and 5 years after treatment
Title
Acute and late toxicity according to NCI CTCAE version 3.0
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Bolla, MD
Organizational Affiliation
CHU de Grenoble - Hopital de la Tronche
Official's Role
Principal Investigator
Facility Information:
Facility Name
European Organization for Research and Treatment of Cancer
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Learn more about this trial
Post-operative or Early Salvage XRT and ADT for High Risk PCa
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