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

NCT00423475 | Completed Phase 3 DMC

• 3 other identifiers: GETUG-AFU 16 - UC-0160/0504EUDRACT-2005-005165-11CDR0000523446
• Study Type: interventional
• Target: 743
• Locations: 1 country
• Sites: 31

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; recurrent prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free (biological and/or clinical) survival

  3.5 years

Secondary Outcomes (6)

• Overall survival

  not yet evaluable

• Metastases-free survival

  not yet evaluable

• Immediate and delayed toxicities

  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

Study Arms (2)

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

Procedure: adjuvant therapy; Radiation: radiation therapy

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

Drug: goserelin acetate; Procedure: adjuvant therapy; Radiation: radiation therapy

Interventions

goserelin acetate DRUG

Also known as: ZOLADEX

II

adjuvant therapy PROCEDURE

I; II

radiation therapy RADIATION

I; II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead
• AstraZeneca: collaborator

Study Sites (31)

Centre Paul Papin

Angers, 49036, France

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94000, France

Location

Centre Hospitalier Intercommunal des Alpes du Sud

Gap, 05007, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Polyclinique des Quatre Pavillons

Lormont, 33310, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

Centre Antoine Lacassagne

Nice, 06088, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

Hopital Saint Joseph

Paris, 75674, France

Location

Hopital Tenon

Paris, 75970, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugene Marquis

Rennes, 35064, France

Location

CHG Roanne

Roanne, F-42300, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Clinique Mutualiste

Saint-Etienne, 42013, France

Location

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Marie Curie

Valence, 26000, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (3)

• 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.

  PMID: 31629656 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.

  PMID: 27160475 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.

  PMID: 25592642 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Goserelin; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Christian Carrie, MD

  Centre Leon Berard

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: October 1, 2006
• Primary Completion: March 1, 2015
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

FR (31)