Clinical trial NCT00667069: Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer
Official title: Randomized, Multicenter Study Comparing the Immediate Adjuvant Radiotherapy Associate With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) vs Delayed Radiotherapy Until Biochemical Relapse Associated With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) in Patients With Operable Prostate Cancer pT3 R1 pN0 or pNx at Intermediate Risk.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: UNICANCER
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2008-04-25
Enrollment: 424
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and radiation therapy soon after surgery or later after surgery is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy soon after surgery to see how well it works compared with giving them later after surgery in treating patients who have undergone surgery for intermediate-risk stage III or stage IV prostate cancer.

Detailed description: OBJECTIVES:

Primary

* Compare the efficacy, in terms of event-free survival at 5 years, of immediate radio-hormonal therapy immediately after prostatectomy for tumor pT2, R1, pN0, or pNx versus radio-hormonal therapy at biochemical relapse.

Secondary

* Compare the overall survival of patients treated with these regimens.
* Compare the metastasis-free survival of these patients.
* Compare the acute and late toxicities of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Compare the functional dependence of patients over 75 years old.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I (delayed treatment): Patients receive triptorelin intramuscularly on day 1 and then 3 months later. Patients also undergo conformal radiotherapy daily, 5 days a week, for 7 weeks. Treatment begins at biochemical relapse (PSA is more than 0.2 ng/mL) and before PSA is more than 2 ng/mL.
* Arm II (immediate treatment): Patients receive treatment as in arm I, but treatment begins within 6 months after surgery.

After completion of study treatment, patients are followed for up to 5 years.

Eligibility criteria: Inclusion criteria:

1. Patient must have undergone curative surgery for a localized adenocarcinoma of the prostate
2. pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease (stage III or IV)
3. PSA ≤0.1 ng/mL after prostatectomy (confirmed at 1 month)
4. May receive treatment within 6 months after surgery
5. Positive margins (tumoral glands in contact with contour ink) on the surgical specimen
6. pN0 or pNx (lymph nodes resected during negative prostatectomy or lymph nodes not resected)
7. No current clinical or biochemical progressive disease
8. Life expectancy ≥10 years
9. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
10. Patient must be affiliated to the social security system
11. Patient must have received the information sheet and signed the consent form

Exclusion criteria:

1. Patient with prostate cancer other than adenocarcinoma
2. Gleason score ≥8 and with seminal vesicles involved
3. pN1 disease (Histologically confirmed nodal invasion during initial lymph node resection)
4. pT2 disease
5. Prior surgical or chemical castration
6. Prior hormonal therapy
7. Prior radiotherapy within 3 months after radical prostatectomy
8. Prior pelvic radiotherapy
9. No history of cancer (except basal cell skin cancer) within 5 years of surgery
10. No known severe hypertension uncontrolled by appropriate therapy (≥160 mm Hg systolic and/or ≥90 mm Hg diastolic)
11. Known hypersensitivity to gonadotropin-releasing hormone or its analogs
12. Contraindication to intramuscular injection
13. Concurrent participation in another interventional study
14. Patients under protective custody or guardianship, unable to comply with the specific requirements of the study or unable to understand the purpose of the study

Primary outcomes:
measure: Event-free survival
timeFrame: From randomization to disease progression or death, up to 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: From randomization to death from any cause, up to 10 years
measure: Metastases-free survival
timeFrame: From randomization to metastases onset, up to 10 years
measure: Acute or chronic toxicity
timeFrame: Throughout study completion, up to 10 years
measure: Quality of life questionnaire - Core 30 (QLQ-C30)
timeFrame: At baseline, 2 years, and 5 years
measure: Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25)
timeFrame: At baseline, 2 years, and 5 years
measure: Functional dependence in patients over 75 years old
timeFrame: At baseline, 2 years, and 5 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Bordeaux
country: France
facility: Institut Bergonie
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Colmar
country: France
facility: Hopitaux Civils de Colmar
city: Creteil
country: France
facility: Centre Hospitalier Universitaire Henri Mondor
city: Lyon
country: France
facility: Centre Leon Berard
city: Montauban
country: France
facility: Clinique du Pont de Chaume
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU Poitiers
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Priest en Jarez
country: France
facility: Institut de Cancerologie de la Loire
city: Saint-Herblain
country: France
facility: Centre Regional Rene Gauducheau
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut Bergonié
name: Pierre Richaud, MD
role: STUDY_CHAIR
References:
citation: Sargos P, Chabaud S, Latorzeff I, Magne N, Benyoucef A, Supiot S, Pasquier D, Abdiche MS, Gilliot O, Graff-Cailleaud P, Silva M, Bergerot P, Baumann P, Belkacemi Y, Azria D, Brihoum M, Soulie M, Richaud P. Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1341-1352. doi: 10.1016/S1470-2045(20)30454-X.
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.