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

July 3, 2014 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • European Organization for Research and Treatment of Cancer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 76 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I
Patients undergo post-operative conformal external beam irradiation for 6.5 weeks.
Radiation: 3-dimensional conformal radiation therapy
Undergo radiotherapy
Experimental: 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.
Radiation: 3-dimensional conformal radiation therapy
Undergo radiotherapy
Drug: antiandrogen therapy
Given systemically
Drug: leuprolide acetate
Given subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Biochemical progression-free survival

Secondary Outcome Measures

Outcome Measure
Overall survival
Clinical progression-free survival
Distant-metastases-free 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Principal Investigator: Michel Bolla, MD, CHU de Grenoble - Hopital de la Tronche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

July 30, 2009

First Submitted That Met QC Criteria

July 30, 2009

First Posted (Estimate)

July 31, 2009

Study Record Updates

Last Update Posted (Estimate)

July 4, 2014

Last Update Submitted That Met QC Criteria

July 3, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-22043-30041
  • EU-20950
  • 2006-002772-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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