Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer

Prostate Cancer Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00667069
• Other study ID #: GETUG-AFU 17 - UC-0160/0702
• Secondary ID: 2007-002495-34CD
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 7, 2008
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 424
• Est. completion date: April 2025
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• triptorelin

Procedure:
• adjuvant therapy

Radiation:
• 3-dimensional conformal radiation therapy

Locations

Country	Name	City	State
France	Hopital Saint Andre	Bordeaux
France	Institut Bergonie	Bordeaux
France	Centre Regional Francois Baclesse	Caen
France	Hopitaux Civils de Colmar	Colmar
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
France	Centre Leon Berard	Lyon
France	Clinique du Pont de Chaume	Montauban
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Hopital Europeen Georges Pompidou	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	CHU Poitiers	Poitiers
France	Centre Henri Becquerel	Rouen
France	Institut de Cancerologie de la Loire	Saint Priest en Jarez
France	Centre Regional Rene Gauducheau	Saint-Herblain
France	Institut Claudius Regaud	Toulouse
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
UNICANCER	Ipsen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival	The event-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (clinical progression, biochemical progression, death)	From randomization to disease progression or death, up to 5 years
Secondary	Overall survival	The overall survival is the length of time from randomization that patients enrolled in the study are still alive.	From randomization to death from any cause, up to 10 years
Secondary	Metastases-free survival	The metastases-free survival is the length of time during and after the treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body.	From randomization to metastases onset, up to 10 years
Secondary	Acute or chronic toxicity	The National Cancer Institute-Common Terminology Criteria for Adverse Events version 3 (NCI-CTCAE v3.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale will assess the severity of sensory neuropathic disorders, this derivative into 5 grades determined by the investigator.	Throughout study completion, up to 10 years
Secondary	Quality of life questionnaire - Core 30 (QLQ-C30)	Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.; The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.; All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.	At baseline, 2 years, and 5 years
Secondary	Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25)	This EORTC prostate cancer specific questionnaire is intended to supplement the QLQ-C30.; The prostate cancer module is a 25-item questionnaire designed for use among patients with localized and metastatic prostate cancer. It includes subscales assessing urinary symptoms (9 items), bowel symptoms (4 items), treatment-related symptoms (6 items), and sexual functioning (6 items). Using a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), patients indicate the degree to which they have experienced symptoms.	At baseline, 2 years, and 5 years
Secondary	Functional dependence in patients over 75 years old	The Lawton Instrumental Activities of Daily Living (IADL) Scale is a self-reported questionnaire to assess independent living skills for older adults. This questionnaire, composed of 31 questions organized into 8 domains (ability to use telephone, shopping, food preparation, housekeeping, laundering, mode of transportation, responsibility for own medications, and ability to handle finances), is designed to identify improvement or deterioration of a person functioning over time. Each domain is scored 0-1 for a summary score ranging from 0 (low function, dependent) to 8 (high function, independent).	At baseline, 2 years, and 5 years