Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
NCT ID: NCT00423475
Last Updated: 2018-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
743 participants
INTERVENTIONAL
2006-10-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
adjuvant therapy
radiation therapy
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
goserelin acetate
adjuvant therapy
radiation therapy
Interventions
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goserelin acetate
adjuvant therapy
radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
MALE
No
Sponsors
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AstraZeneca
INDUSTRY
UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Christian Carrie, MD
Role: STUDY_CHAIR
Centre Leon Berard
Locations
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Centre Paul Papin
Angers, , France
Institut Sainte Catherine
Avignon, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, , France
Institut Bergonie
Bordeaux, , France
Centre Regional Francois Baclesse
Caen, , France
Hopital Louis Pasteur
Colmar, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Centre Hospitalier Intercommunal des Alpes du Sud
Gap, , France
Centre Oscar Lambret
Lille, , France
Polyclinique des Quatre Pavillons
Lormont, , France
Centre Leon Berard
Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Clinique Hartmann
Neuilly-sur-Seine, , France
Centre Antoine Lacassagne
Nice, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Saint-Louis
Paris, , France
Hopital Saint Joseph
Paris, , France
Hopital Tenon
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Poitiers
Poitiers, , France
Institut Jean Godinot
Reims, , France
Centre Eugene Marquis
Rennes, , France
CHG Roanne
Roanne, , France
Clinique Armoricaine De Radiologie
Saint-Brieuc, , France
Centre Rene Huguenin
Saint-Cloud, , France
Clinique Mutualiste
Saint-Etienne, , France
Institut de Cancerologie de la Loire
Saint-Priest-en-Jarez, , France
Institut Claudius Regaud
Toulouse, , France
Centre Marie Curie
Valence, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Countries
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References
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Carrie C, Magne N, Burban-Provost P, Sargos P, Latorzeff I, Lagrange JL, Supiot S, Belkacemi Y, Peiffert D, Allouache N, Dubray BM, Servagi-Vernat S, Suchaud JP, Crehange G, Guerif S, Brihoum M, Barbier N, Graff-Cailleaud P, Ruffion A, Dussart S, Ferlay C, Chabaud S. Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial. Lancet Oncol. 2019 Dec;20(12):1740-1749. doi: 10.1016/S1470-2045(19)30486-3. Epub 2019 Oct 16.
Carrie C, Hasbini A, de Laroche G, Richaud P, Guerif S, Latorzeff I, Supiot S, Bosset M, Lagrange JL, Beckendorf V, Lesaunier F, Dubray B, Wagner JP, N'Guyen TD, Suchaud JP, Crehange G, Barbier N, Habibian M, Ferlay C, Fourneret P, Ruffion A, Dussart S. Salvage radiotherapy with or without short-term hormone therapy for rising prostate-specific antigen concentration after radical prostatectomy (GETUG-AFU 16): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol. 2016 Jun;17(6):747-756. doi: 10.1016/S1470-2045(16)00111-X. Epub 2016 May 6.
Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prise E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.
Other Identifiers
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EUDRACT-2005-005165-11
Identifier Type: -
Identifier Source: secondary_id
CDR0000523446
Identifier Type: -
Identifier Source: secondary_id
GETUG-AFU 16 - UC-0160/0504
Identifier Type: -
Identifier Source: org_study_id
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