Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT00423475
First received: January 16, 2007
Last updated: February 2, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: goserelin acetate
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • Progression-free (biological and/or clinical) survival [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: not yet evaluable ] [ Designated as safety issue: No ]
  • Metastases-free survival [ Time Frame: not yet evaluable ] [ Designated as safety issue: No ]
  • Immediate and delayed toxicities [ Time Frame: not yet evaluable ] [ Designated as safety issue: Yes ]
  • Delay in reaching the prostate-specific antigen nadir [ Time Frame: not yet evaluable ] [ Designated as safety issue: No ]
  • Quality of life at 1 and 5 years after radiotherapy [ Time Frame: not yet evaluable ] [ Designated as safety issue: No ]
  • Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over [ Time Frame: not yet evaluable ] [ Designated as safety issue: No ]

Enrollment: 743
Study Start Date: October 2006
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
Exclusive Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
Procedure: adjuvant therapy Radiation: radiation therapy
Experimental: II
Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
Drug: goserelin acetate
Other Name: ZOLADEX
Procedure: adjuvant therapy Radiation: radiation therapy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423475

Locations
France
Centre Paul Papin
Angers, France, 49036
Institut Sainte Catherine
Avignon, France, 84082
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Institut Bergonie
Bordeaux, France, 33076
Centre Regional Francois Baclesse
Caen, France, 14076
Hopital Louis Pasteur
Colmar, France, 68024
Centre Hospitalier Universitaire Henri Mondor
Creteil, France, 94000
Centre Hospitalier Intercommunal des Alpes du Sud
Gap, France, 05007
Centre Oscar Lambret
Lille, France, 59020
Polyclinique des Quatre Pavillons
Lormont, France, 33310
Centre Leon Berard
Lyon, France, 69373
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Clinique Hartmann
Neuilly sur Seine, France, 92200
Centre Antoine Lacassagne
Nice, France, 06088
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Saint Joseph
Paris, France, 75674
Hopital Saint-Louis
Paris, France, 75475
Hopital Tenon
Paris, France, 75970
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
CHU Poitiers
Poitiers, France, 86021
Institut Jean Godinot
Reims, France, 51056
Centre Eugene Marquis
Rennes, France, 35064
CHG Roanne
Roanne, France, F-42300
Clinique Armoricaine De Radiologie
Saint Brieuc, France, F-22015
Centre Rene Huguenin
Saint Cloud, France, 92211
Clinique Mutualiste
Saint Etienne, France, 42013
Institut de Cancerologie de la Loire
Saint Priest en Jarez, France, 42270
Institut Claudius Regaud
Toulouse, France, 31052
Centre Marie Curie
Valence, France, 26000
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Christian Carrie, MD Centre Leon Berard
  More Information

No publications provided

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00423475     History of Changes
Other Study ID Numbers: CDR0000523446, FRE-FNCLCC-GETUG-16/0504, EU-20668, EUDRACT-2005-005165
Study First Received: January 16, 2007
Last Updated: February 2, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Ethics Committee

Keywords provided by UNICANCER:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Goserelin
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 26, 2015