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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2007

Sponsored by: Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00423475
  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
Procedure: adjuvant therapy
Procedure: radiation therapy
Phase III

MedlinePlus related topics:   Cancer    Prostate Cancer   

Drug Information available for:   Goserelin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label
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

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

Sponsors and Collaborators
Federation Nationale des Centres de Lutte Contre le Cancer

Investigators
Study Chair:     Christian Carrie, MD     Centre Leon Berard    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000523446, FRE-FNCLCC-GETUG-16/0504, EU-20668, EUDRACT-2005-005165
First Received:   January 16, 2007
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00423475
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate  
stage II prostate cancer  
stage III prostate cancer  
recurrent prostate cancer  
stage IV prostate cancer  

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Goserelin
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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