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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT-2005-005165-11 | |||
| CDR0000523446 |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Active Comparator | 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 |
|
| II | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| goserelin acetate | Drug |
|
| |
| adjuvant therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free (biological and/or clinical) survival | 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | not yet evaluable | |
| Metastases-free survival | not yet evaluable | |
| Immediate and delayed toxicities |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Prostate-specific antigen (PSA) meeting the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Carrie, MD | Centre Leon Berard | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Angers | 49036 | France | |||
| Institut Sainte Catherine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31629656 | Derived | 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. | |
| 27160475 |
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| Procedure |
|
| radiation therapy | Radiation |
|
| not yet evaluable |
| Delay in reaching the prostate-specific antigen nadir | not yet evaluable |
| Quality of life at 1 and 5 years after radiotherapy | not yet evaluable |
| Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over | not yet evaluable |
| Avignon |
| 84082 |
| France |
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz | Besançon | 25030 | France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Regional Francois Baclesse | Caen | 14076 | France |
| Hopital Louis Pasteur | Colmar | 68024 | France |
| Centre Hospitalier Universitaire Henri Mondor | Créteil | 94000 | France |
| Centre Hospitalier Intercommunal des Alpes du Sud | Gap | 05007 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Polyclinique des Quatre Pavillons | Lormont | 33310 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Marseille | 13273 | France |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| Clinique Hartmann | Neuilly-sur-Seine | 92200 | France |
| Centre Antoine Lacassagne | Nice | 06088 | France |
| Hopital Europeen Georges Pompidou | Paris | 75015 | France |
| Hopital Saint-Louis | Paris | 75475 | France |
| Hopital Saint Joseph | Paris | 75674 | France |
| Hopital Tenon | Paris | 75970 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| CHU Poitiers | Poitiers | 86021 | France |
| Institut Jean Godinot | Reims | 51056 | France |
| Centre Eugene Marquis | Rennes | 35064 | France |
| CHG Roanne | Roanne | F-42300 | France |
| Clinique Armoricaine De Radiologie | Saint-Brieuc | F-22015 | France |
| Centre Rene Huguenin | Saint-Cloud | 92211 | France |
| Clinique Mutualiste | Saint-Etienne | 42013 | France |
| Institut de Cancerologie de la Loire | Saint-Priest-en-Jarez | 42270 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| Centre Marie Curie | Valence | 26000 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Derived |
| 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. |
| 25592642 | Derived | 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. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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