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

Prostate Cancer Clinical Trial

Official title:

Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00423475
• Other study ID #: GETUG-AFU 16 - UC-0160/0504
• Secondary ID: EUDRACT-2005-005
• Status: Completed
• Phase: Phase 3
• Start date: October 2006

Study information

• Verified date: May 2018
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 743
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Localized disease treated with surgery only

• pT2, pT3, or pT4

• pN0 or pNx

• No clinical signs of progressive disease

• Prostate-specific antigen (PSA) meeting the following criteria:

• PSA = 0.1 ng/mL after prostatectomy

• PSA = 0.2 ng/mL and < 2 ng/mL at study entry

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Life expectancy = 10 years

• No other cancer in the past 5 years except for treated basal cell skin cancer

• No known pituitary gland adenoma

• No uncontrolled hypertension (i.e., blood pressure = 160 mm Hg systolic and/or 90 mm Hg diastolic)

• No geographical, social, or psychological condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior hormonal therapy

• No prior pelvic radiotherapy

• No prior surgical or chemical castration

• At least 6 months since surgery for biological recurrence

• No other concurrent anticancer therapy

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• goserelin acetate

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	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	Centre Leon Berard	Lyon
France	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Marseille
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Clinique Hartmann	Neuilly sur Seine
France	Centre Antoine Lacassagne	Nice
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital Saint Joseph	Paris
France	Hopital Saint-Louis	Paris
France	Hopital Tenon	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	CHU Poitiers	Poitiers
France	Institut Jean Godinot	Reims
France	Centre Eugene Marquis	Rennes
France	CHG Roanne	Roanne
France	Clinique Armoricaine De Radiologie	Saint Brieuc
France	Centre Rene Huguenin	Saint Cloud
France	Clinique Mutualiste	Saint Etienne
France	Institut de Cancerologie de la Loire	Saint Priest en Jarez
France	Institut Claudius Regaud	Toulouse
France	Centre Marie Curie	Valence
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy

Sponsors (2)

Lead Sponsor	Collaborator
UNICANCER	AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free (biological and/or clinical) survival		3.5 years
Secondary	Overall survival		not yet evaluable
Secondary	Metastases-free survival		not yet evaluable
Secondary	Immediate and delayed toxicities		not yet evaluable
Secondary	Delay in reaching the prostate-specific antigen nadir		not yet evaluable
Secondary	Quality of life at 1 and 5 years after radiotherapy		not yet evaluable
Secondary	Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over		not yet evaluable