Radiation Therapy With or Without Hormone Therapy in Treating Patients Who Have Undergone Surgery For Stage I, Stage II, or Stage III Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: July 30, 2009
Last updated: February 18, 2011
Last verified: May 2010

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.

Condition Intervention Phase
Prostate Cancer
Drug: antiandrogen therapy
Drug: leuprolide acetate
Radiation: 3-dimensional conformal radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-operative External Radiotherapy Combined With Concomitant and Adjuvant Hormonal Treatment Versus Postoperative External Radiotherapy Alone in Pathological Stage pT3a-b R0-1 N0M0 / pT2R1 N0M0, Gleason Score 5-10 Prostatic Carcinoma. A Phase III Study

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Biochemical progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical progression-free survival [ Designated as safety issue: No ]
  • Distant-metastases-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Acute and late toxicity according to NCI CTCAE version 3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: May 2009
Arms Assigned Interventions
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.
Drug: antiandrogen therapy
Given systemically
Drug: leuprolide acetate
Given subcutaneously
Radiation: 3-dimensional conformal radiation therapy
Undergo radiotherapy

Detailed Description:


  • 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.


Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949962

European Organization for Research and Treatment of Cancer Recruiting
Grenoble, France, 38043
Contact: Michel Bolla, MD    33-476-765-506    mbolla@chu-grenoble.fr   
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Principal Investigator: Michel Bolla, MD CHU de Grenoble - Hopital de la Tronche
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00949962     History of Changes
Other Study ID Numbers: CDR0000644215, EORTC-22043, EORTC-22043-30041, EU-20950, EUDRACT-2006-002772-17
Study First Received: July 30, 2009
Last Updated: February 18, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on April 17, 2014