Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: adjuvant therapy; Drug: goserelin acetate; Radiation: radiation therapy

• Registration Number: NCT00423475
• Lead Sponsor: UNICANCER

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer.

Detailed Description

OBJECTIVES:

Primary

* Compare the efficacy of adjuvant radiotherapy with vs without concurrent goserelin, in terms of biological and/or clinical progression-free survival, in patients who have undergone surgery for recurrent or refractory prostate cancer.

Secondary

* Compare overall survival of patients treated with these regimens.

* Compare metastases-free survival of patients treated with these regimens.

* Compare the immediate and delayed toxicities of these regimens.

* Compare the delay in reaching the prostate-specific antigen nadir in patients treated with these regimens.

* Compare the quality of life at 1 and 5 years after radiotherapy in these patients.

* Compare the functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over.

OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.

* Arm II: Patients undergo radiotherapy as in arm I. Patients also receive goserelin subcutaneously on day 1 and again 3 months later.

Quality of life is assessed periodically.

After completion of study therapy, patients are followed periodically for 10 years.

PROJECTED ACCRUAL: A total of 466 patients will be accrued for this study.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-01-16
• Study First Submitted QC: 2007-01-16
• Study First Posted: 2007-01-18
• Primary Completion: 2015-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 743

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	adjuvant therapy	Exclusive Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
I	radiation therapy	Exclusive Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
II	goserelin acetate	Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
II	adjuvant therapy	Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
II	radiation therapy	Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer

Primary Outcome Measures

Name	Time	Method
Progression-free (biological and/or clinical) survival	3.5 years

Secondary Outcome Measures

Name	Time	Method
Immediate and delayed toxicities	not yet evaluable
Delay in reaching the prostate-specific antigen nadir	not yet evaluable
Quality of life at 1 and 5 years after radiotherapy	not yet evaluable
Overall survival	not yet evaluable
Metastases-free survival	not yet evaluable
Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over	not yet evaluable

Trial Locations

Locations (31)

Centre Paul Papin; 🇫🇷 Angers, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz; 🇫🇷 Besancon, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

Hopital Louis Pasteur; 🇫🇷 Colmar, France

Centre Hospitalier Universitaire Henri Mondor; 🇫🇷 Creteil, France

Centre Hospitalier Intercommunal des Alpes du Sud; 🇫🇷 Gap, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Polyclinique des Quatre Pavillons; 🇫🇷 Lormont, France

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