Back to resultsTriptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Active
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
triptorelin
adjuvant therapy
3-dimensional conformal radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer
Eligibility Criteria
Inclusion criteria:
- Patient must have undergone curative surgery for a localized adenocarcinoma of the prostate
- pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease (stage III or IV)
- PSA ≤0.1 ng/mL after prostatectomy (confirmed at 1 month)
- May receive treatment within 6 months after surgery
- Positive margins (tumoral glands in contact with contour ink) on the surgical specimen
- pN0 or pNx (lymph nodes resected during negative prostatectomy or lymph nodes not resected)
- No current clinical or biochemical progressive disease
- Life expectancy ≥10 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patient must be affiliated to the social security system
- Patient must have received the information sheet and signed the consent form
Exclusion criteria:
- Patient with prostate cancer other than adenocarcinoma
- Gleason score ≥8 and with seminal vesicles involved
- pN1 disease (Histologically confirmed nodal invasion during initial lymph node resection)
- pT2 disease
- Prior surgical or chemical castration
- Prior hormonal therapy
- Prior radiotherapy within 3 months after radical prostatectomy
- Prior pelvic radiotherapy
- No history of cancer (except basal cell skin cancer) within 5 years of surgery
- No known severe hypertension uncontrolled by appropriate therapy (≥160 mm Hg systolic and/or ≥90 mm Hg diastolic)
- Known hypersensitivity to gonadotropin-releasing hormone or its analogs
- Contraindication to intramuscular injection
- Concurrent participation in another interventional study
- 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
Sites / Locations
- Hopital Saint Andre
- Institut Bergonie
- Centre Regional Francois Baclesse
- Hopitaux Civils de Colmar
- Centre Hospitalier Universitaire Henri Mondor
- Centre Leon Berard
- Clinique du Pont de Chaume
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
- Hopital Europeen Georges Pompidou
- Centre Hospitalier Lyon Sud
- CHU Poitiers
- Centre Henri Becquerel
- Institut de Cancerologie de la Loire
- Centre Regional Rene Gauducheau
- Institut Claudius Regaud
- Centre Alexis Vautrin
- Institut Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
A Relapse
B Immediate treatment
Arm Description
Radiotherapy and Hormonotherapy only if relapse
Radiotherapy and Hormonotherapy at randomization
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Overall survival
The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
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.
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.
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.
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.
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).
Full Information
NCT ID
NCT00667069
First Posted
April 24, 2008
Last Updated
April 13, 2023
Sponsor
UNICANCER
Collaborators
Ipsen
1. Study Identification
Unique Protocol Identification Number
NCT00667069
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 7, 2008 (Actual)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
Collaborators
Ipsen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
424 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A Relapse
Arm Type
Other
Arm Description
Radiotherapy and Hormonotherapy only if relapse
Arm Title
B Immediate treatment
Arm Type
Experimental
Arm Description
Radiotherapy and Hormonotherapy at randomization
Intervention Type
Drug
Intervention Name(s)
triptorelin
Other Intervention Name(s)
Decapeptyl
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
3-dimensional conformal radiation therapy
Primary Outcome Measure Information:
Title
Event-free survival
Description
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)
Time Frame
From randomization to disease progression or death, up to 5 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Time Frame
From randomization to death from any cause, up to 10 years
Title
Metastases-free survival
Description
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.
Time Frame
From randomization to metastases onset, up to 10 years
Title
Acute or chronic toxicity
Description
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.
Time Frame
Throughout study completion, up to 10 years
Title
Quality of life questionnaire - Core 30 (QLQ-C30)
Description
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.
Time Frame
At baseline, 2 years, and 5 years
Title
Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25)
Description
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.
Time Frame
At baseline, 2 years, and 5 years
Title
Functional dependence in patients over 75 years old
Description
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).
Time Frame
At baseline, 2 years, and 5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Patient must have undergone curative surgery for a localized adenocarcinoma of the prostate
pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease (stage III or IV)
PSA ≤0.1 ng/mL after prostatectomy (confirmed at 1 month)
May receive treatment within 6 months after surgery
Positive margins (tumoral glands in contact with contour ink) on the surgical specimen
pN0 or pNx (lymph nodes resected during negative prostatectomy or lymph nodes not resected)
No current clinical or biochemical progressive disease
Life expectancy ≥10 years
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Patient must be affiliated to the social security system
Patient must have received the information sheet and signed the consent form
Exclusion criteria:
Patient with prostate cancer other than adenocarcinoma
Gleason score ≥8 and with seminal vesicles involved
pN1 disease (Histologically confirmed nodal invasion during initial lymph node resection)
pT2 disease
Prior surgical or chemical castration
Prior hormonal therapy
Prior radiotherapy within 3 months after radical prostatectomy
Prior pelvic radiotherapy
No history of cancer (except basal cell skin cancer) within 5 years of surgery
No known severe hypertension uncontrolled by appropriate therapy (≥160 mm Hg systolic and/or ≥90 mm Hg diastolic)
Known hypersensitivity to gonadotropin-releasing hormone or its analogs
Contraindication to intramuscular injection
Concurrent participation in another interventional study
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Richaud, MD
Organizational Affiliation
Institut Bergonié
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Hopitaux Civils de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Clinique du Pont de Chaume
City
Montauban
ZIP/Postal Code
82017
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Institut de Cancerologie de la Loire
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Centre Regional Rene Gauducheau
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33002438
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.
Results Reference
derived
PubMed Identifier
25592642
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.
Results Reference
derived
Learn more about this trial
Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer
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