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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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ClinicalTrials.gov Identifier: NCT00667069
Recruitment Status : Active, not recruiting
First Posted : April 25, 2008
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
UNICANCER

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: triptorelin Procedure: adjuvant therapy Radiation: 3-dimensional conformal radiation therapy Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 718 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 2008
Estimated Primary Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer




Primary Outcome Measures :
  1. Event-free survival (clinical progression, biochemical progression, death) at 5 years

Secondary Outcome Measures :
  1. Overall survival
  2. Metastases-free survival
  3. Acute or chronic toxicity
  4. Quality of life
  5. Functional dependence in patients over 75 years old


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease (stage III or IV)
    • Localized disease
    • pN0 or pNx (lymph nodes resected during negative prostatectomy or lymph nodes not resected)
    • No histologically confirmed nodal involvement during initial surgery (pN1 disease)
    • No pT2 disease
    • No tumors of other histology than adenocarcinoma
  • Must have undergone curative surgery in the past 6 months

    • Positive margins (tumoral glands in contact with contour ink)
  • No current clinical or biochemical disease

    • PSA ≤ 0.1 ng/mL after prostatectomy (confirmed at 1 month)
  • Gleason score < 8 with no seminal vesicles involved

PATIENT CHARACTERISTICS:

  • ECOG performance status 0 or 1
  • Life expectancy ≥ 10 years
  • Affiliated with social security program
  • No history of cancer within 5 years of surgery except basal cell skin cancer
  • No known severe hypertension uncontrolled by appropriate therapy (≥ 160 mm Hg systolic and/or ≥ 90 mm Hg diastolic)
  • No known hypersensitivity to gonadotropin-releasing hormone or its analogs
  • No contraindication of intramuscular injection
  • No patients who are deprived of liberty or under guardianship
  • Not unable to undergo medical monitoring due to geographical, social, or psychological reasons

PRIOR CONCURRENT THERAPY:

  • No prior surgical or chemical castration
  • No prior hormonal therapy
  • No prior radiotherapy within 3 months after radical prostatectomy
  • No prior pelvic radiotherapy
  • No concurrent participation in another study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667069


Locations
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France
Hopital Saint Andre
Bordeaux, France, 33075
Institut Bergonie
Bordeaux, France, 33076
Centre Regional Francois Baclesse
Caen, France, 14076
Hopitaux Civils de Colmar
Colmar, France, 68024
Centre Hospitalier Universitaire Henri Mondor
Creteil, France, 94000
Centre Leon Berard
Lyon, France, 69373
Clinique du Pont de Chaume
Montauban, France, 82017
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, France, 44805
Hopital Europeen Georges Pompidou
Paris, France, 75015
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
CHU Poitiers
Poitiers, France, 86021
Centre Henri Becquerel
Rouen, France, 76038
Institut de Cancerologie de la Loire
Saint Priest en Jarez, France, 42270
Institut Claudius Regaud
Toulouse, France, 31052
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
UNICANCER
Ipsen
Investigators
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Study Chair: Pierre Richaud, MD Institut Bergonié

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00667069     History of Changes
Other Study ID Numbers: GETUG-AFU 17 - UC-0160/0702
EUDRACT-2007-002495-34
CDR0000577485
First Posted: April 25, 2008    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Keywords provided by UNICANCER:
adenocarcinoma of the prostate
stage III prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents