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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00423475
First received: January 16, 2007
Last updated: February 18, 2011
Last verified: January 2007
History of Changes
  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
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:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Metastases-free survival [ Designated as safety issue: No ]
  • Immediate and delayed toxicities [ Designated as safety issue: Yes ]
  • Delay in reaching the prostate-specific antigen nadir [ Designated as safety issue: No ]
  • Quality of life at 1 and 5 years after radiotherapy [ Designated as safety issue: No ]
  • Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over [ Designated as safety issue: No ]

Estimated Enrollment: 466
Study Start Date: October 2006
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423475

Locations
France
Centre Paul Papin Recruiting
Angers, France, 49036
Contact: Pierre Pabot du Chatelard     33-2-4135-2700        
Institut Sainte Catherine Recruiting
Avignon, France, 84082
Contact: Bruno Chauvet, MD     33-4-9027-6182        
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Jean-Francois Bosset, MD     33-381-668310     jean-francois.bosset@ufc-chu.univ-fcomte.fr    
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Pierre Richaud, MD     33-5-56-33-33-20     richaud@bergonie.org    
Centre Regional Francois Baclesse Recruiting
Caen, France, 14076
Contact: Francois Lesaunier, MD     33-231-455-050     f.lesaunier@baclesse.fr    
Hopital Louis Pasteur Recruiting
Colmar, France, 68024
Contact: Nasreddine Feham, MD     33-3-8912-4225        
Centre Hospitalier Universitaire Henri Mondor Recruiting
Creteil, France, 94000
Contact: Jean-Leon Lagrange, MD     33-1-49-814-524     jean-leon.lagrange@hmn.aphp.fr    
Centre Hospitalier Intercommunal des Alpes du Sud Recruiting
Gap, France, 05007
Contact: Abdellatif Zribi, MD     33-4-9240-6785        
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Eric Lartigau, MD, PhD     33-3-2029-5911     e-lartigau@o-lambret.fr    
Polyclinique des Quatre Pavillons Recruiting
Lormont, France, 33310
Contact: Pierre Guichard, MD     33-5-5780-8489        
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Christian Carrie, MD     33-4-78-78-26-45     carrie@lyon.fnclcc.fr    
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Recruiting
Marseille, France, 13273
Contact: Naji Salem, MD     33-4-9122-3637        
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Jean-Bernard Dubois, MD     33-4-6761-3100        
Clinique Hartmann Recruiting
Neuilly sur Seine, France, 92200
Contact: Jean-Michel Vannetzel, MD     33-1-4759-0000        
Centre Antoine Lacassagne Recruiting
Nice, France, 06088
Contact: J. M. Hannoun-Levi, MD     33-49-203-1000        
Hopital Saint-Louis Recruiting
Paris, France, 75475
Contact: Christophe Hennequin, PhD     33-1-4249-4949     christophe.hennequin@sls.ap-hop-paris.fr    
Hopital Saint Joseph Recruiting
Paris, France, 75674
Contact: Gael Deplanque, MD, MSC, PhD     33-1-4412-7626     gdeplanque@hpsj.fr    
Hopital Tenon Recruiting
Paris, France, 75970
Contact: E Touboul, MD     33-56-01-70-00 ext 6210     emmanuel.touboul@tnn.ap-hop-paris.fr    
Hopital Europeen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Martin Y. Housset, MD     33-1-56-093-401     martin.housset@freesbee.fr    
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69495
Contact: Pascale Romestaing, MD     33-4-78-86-42-51     pascale.romestaing@chu-lyon.fr    
CHU Poitiers Recruiting
Poitiers, France, 86021
Contact: Stephane Guerif     33-5-4944-4485        
Institut Jean Godinot Recruiting
Reims, France, 51056
Contact: Tan Dat Nguyen, MD     33-03-2650-4351     tandat.nguyen@reims.fnclcc.fr    
Centre Eugene Marquis Recruiting
Rennes, France, 35064
Contact: Elizabeth Le Prise, MD     33-2-9925-3000     elptrennes@fnclcc.fr    
CHG Roanne Recruiting
Roanne, France, F-42300
Contact: Jean Philippe Suchaud     33-4-7744-3396        
Clinique Armoricaine De Radiologie Recruiting
Saint Brieuc, France, F-22015
Contact: Ali Hasbini, MD     33-2-9675-2220     a.hassbini@clin-armoricaine.fr    
Centre Rene Huguenin Recruiting
Saint Cloud, France, 92211
Contact: P. Moisson, MD     33-1-47-111-515        
Clinique Mutualiste Recruiting
Saint Etienne, France, 42013
Contact: Nicolas Mottet, MD, PhD     33-477-12-11-47     nmottet@mutualite-loire.com    
Institut de Cancerologie de la Loire Recruiting
Saint Priest en Jarez, France, 42270
Contact: Guy De Laroche, MD     33-4-7791-7102        
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Jean-Marc Bachaud, MD     33-5-6142-4242        
Centre Marie Curie Recruiting
Valence, France, 26000
Contact: Sebastien Clippe, MD     33-47-581-3381     dr.clippe@orange.fr    
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Veronique Beckendorf     33-3-8359-8425        
Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Christian Carrie, MD Centre Leon Berard
  More Information

No publications provided

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 18, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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 Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Adjuvants, Immunologic
 Goserelin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013