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

Sponsor:	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 acetate Procedure: adjuvant therapy Radiation: radiation therapy	Phase III

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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Goserelin

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

Federation Nationale des Centres de Lutte Contre le Cancer

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 February 12, 2012