Post-operative or Early Salvage XRT and ADT for High Risk PCa

NCT ID: NCT00949962

Last Updated: 2014-07-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2016-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients undergo post-operative conformal external beam irradiation for 6.5 weeks.

Group Type: ACTIVE_COMPARATOR

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

Undergo radiotherapy

Arm II

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.

Group Type: EXPERIMENTAL

antiandrogen therapy

Intervention Type: DRUG

Given systemically

leuprolide acetate

Intervention Type: DRUG

Given subcutaneously

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

Undergo radiotherapy

Interventions

antiandrogen therapy

Given systemically

Intervention Type: DRUG

leuprolide acetate

Given subcutaneously

Intervention Type: DRUG

3-dimensional conformal radiation therapy

Undergo radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Bolla, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Grenoble - Hopital de la Tronche

Locations

European Organization for Research and Treatment of Cancer

Grenoble, , France

Countries

France

Other Identifiers

EU-20950

Identifier Type: -

Identifier Source: secondary_id

2006-002772-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EORTC-22043-30041

Identifier Type: -

Identifier Source: org_study_id