Clinical trial NCT00423475: Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
recurrent prostate cancer
stage IV prostate cancer
Lead sponsor: UNICANCER
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2007-01-18
Enrollment: 743
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free (biological and/or clinical) survival
timeFrame: 3.5 years
Secondary outcomes:
measure: Overall survival
timeFrame: not yet evaluable
measure: Metastases-free survival
timeFrame: not yet evaluable
measure: Immediate and delayed toxicities
timeFrame: not yet evaluable
measure: Delay in reaching the prostate-specific antigen nadir
timeFrame: not yet evaluable
measure: Quality of life at 1 and 5 years after radiotherapy
timeFrame: not yet evaluable
measure: Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over
timeFrame: not yet evaluable
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besancon
country: France
facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonie
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Colmar
country: France
facility: Hopital Louis Pasteur
city: Creteil
country: France
facility: Centre Hospitalier Universitaire Henri Mondor
city: Gap
country: France
facility: Centre Hospitalier Intercommunal des Alpes du Sud
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lormont
country: France
facility: Polyclinique des Quatre Pavillons
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
city: Neuilly sur Seine
country: France
facility: Clinique Hartmann
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Hopital Saint Joseph
city: Paris
country: France
facility: Hopital Tenon
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Roanne
country: France
facility: CHG Roanne
city: Saint Brieuc
country: France
facility: Clinique Armoricaine De Radiologie
city: Saint Cloud
country: France
facility: Centre Rene Huguenin
city: Saint Etienne
country: France
facility: Clinique Mutualiste
city: Saint Priest en Jarez
country: France
facility: Institut de Cancerologie de la Loire
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Valence
country: France
facility: Centre Marie Curie
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Centre Leon Berard
name: Christian Carrie, MD
role: STUDY_CHAIR
References:
citation: Carrie C, Magne N, Burban-Provost P, Sargos P, Latorzeff I, Lagrange JL, Supiot S, Belkacemi Y, Peiffert D, Allouache N, Dubray BM, Servagi-Vernat S, Suchaud JP, Crehange G, Guerif S, Brihoum M, Barbier N, Graff-Cailleaud P, Ruffion A, Dussart S, Ferlay C, Chabaud S. Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial. Lancet Oncol. 2019 Dec;20(12):1740-1749. doi: 10.1016/S1470-2045(19)30486-3. Epub 2019 Oct 16.
citation: Carrie C, Hasbini A, de Laroche G, Richaud P, Guerif S, Latorzeff I, Supiot S, Bosset M, Lagrange JL, Beckendorf V, Lesaunier F, Dubray B, Wagner JP, N'Guyen TD, Suchaud JP, Crehange G, Barbier N, Habibian M, Ferlay C, Fourneret P, Ruffion A, Dussart S. Salvage radiotherapy with or without short-term hormone therapy for rising prostate-specific antigen concentration after radical prostatectomy (GETUG-AFU 16): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol. 2016 Jun;17(6):747-756. doi: 10.1016/S1470-2045(16)00111-X. Epub 2016 May 6.
citation: Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prise E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.