Radiation Therapy With or Without Goserelin 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

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.

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.

Michael Jonathan Kucharczyk, James Man Git Tsui, Farzin Khosrow‐Khavar, Boris Bahoric, Luís Souhami et al. (10 authors)

Frontiers in Oncology2020-03-126 citations

10.3389/fonc.2020.00312

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.

Carrie C, Magné 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.

2019-10-16170 citations

10.1016/s1470-2045(19)30486-3

Interest of short hormonotherapy (HT) associated with radiotherapy (RT) as salvage treatment for metastatic free survival (MFS) after radical prostatectomy (RP): Update at 9 years of the GETUG-AFU 16 phase III randomized trial (NCT00423475).

C. Carrié, Nicolas Magné, Patricia Burban-Provost, Paul Sargos, I. Latorzeff et al. (19 authors)

Journal of Clinical Oncology2019-05-207 citations

10.1200/jco.2019.37.15_suppl.5001

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.

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, Créhange G, Barbier N, Habibian M, Ferlay C, Fourneret P, Ruffion A, Dussart S.

2016-05-06255 citations

10.1016/s1470-2045(16)00111-x

Interest of short hormonotherapy (HT) associated with radiotherapy (RT) as salvage treatment for biological relapse (BR) after radical prostatectomy (RP): Results of the GETUG-AFU 16 phase III randomized trial—NCT00423475.

C. Carrié, Ali Hasbini, Guy de Laroche, Muriel Habibian, Pierre Richaud et al. (20 authors)

Journal of Clinical Oncology2015-05-2014 citations

10.1200/jco.2015.33.15_suppl.5006

Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials

Boris Campillo‐Gimenez, Camille Buscail, Oussama Zékri, Brigitte Laguerre, É. Le Prisé et al. (7 authors)

Trials2015-01-1523 citations

10.1186/s13063-014-0535-7

Interventions

DRUGgoserelin acetate

PROCEDUREadjuvant therapy

RADIATIONradiation therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 120 Years

Healthy volunteers

No

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Progression-free (biological and/or clinical) survival	3.5 years

Secondary

Measure	Time frame
Metastases-free survival	not yet evaluable
Immediate and delayed toxicities	not yet evaluable
Overall survival	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
Delay in reaching the prostate-specific antigen nadir	not yet evaluable

Countries

France

Outcome results

None listed