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

• ClinicalTrials.gov Identifier: NCT00423475
• Recruitment Status: Completed
• First Posted: January 18, 2007
• Last Update Posted: May 17, 2018
• Sponsor: UNICANCER
• Collaborator: AstraZeneca
• Information provided by (Responsible Party): UNICANCER

Tracking Information

• First Submitted Date: January 16, 2007
• First Posted Date: January 18, 2007
• Last Update Posted Date: May 17, 2018
• Actual Study Start Date: October 2006
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 2, 2015): Progression-free (biological and/or clinical) survival [ Time Frame: 3.5 years ]
• Original Primary Outcome Measures (submitted: January 16, 2007): Progression-free (biological and/or clinical) survival

Current Secondary Outcome Measures (submitted: February 2, 2015)

• Overall survival [ Time Frame: not yet evaluable ]
• Metastases-free survival [ Time Frame: not yet evaluable ]
• Immediate and delayed toxicities [ Time Frame: not yet evaluable ]
• Delay in reaching the prostate-specific antigen nadir [ Time Frame: not yet evaluable ]
• Quality of life at 1 and 5 years after radiotherapy [ Time Frame: not yet evaluable ]
• Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over [ Time Frame: not yet evaluable ]

Original Secondary Outcome Measures (submitted: January 16, 2007)

• Overall survival
• Metastases-free survival
• Immediate and delayed toxicities
• Delay in reaching the prostate-specific antigen nadir
• Quality of life at 1 and 5 years after radiotherapy
• Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

• Drug: goserelin acetate
  Other Name: ZOLADEX
• Procedure: adjuvant therapy
• Radiation: radiation therapy

Study Arms

• Active Comparator: 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
  Interventions:

  • Procedure: adjuvant therapy
  • Radiation: radiation therapy
• Experimental: 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
  Interventions:

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

Publications *

• 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. Erratum In: Lancet Oncol. 2016 Jun;17 (6):e223. Lancet Oncol. 2019 Jun;20(6):e293.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 2, 2015): 743
• Original Enrollment (submitted: January 16, 2007): 466
• Study Completion Date: Not Provided
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 120 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00423475
• Other Study ID Numbers: GETUG-AFU 16 - UC-0160/0504; EUDRACT-2005-005165-11; CDR0000523446
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: UNICANCER
• Original Responsible Party: Not Provided
• Current Study Sponsor: UNICANCER
• Original Study Sponsor: Same as current
• Collaborators: AstraZeneca

Investigators

• Study Chair: Christian Carrie, MD; Centre Leon Berard

• PRS Account: UNICANCER
• Verification Date: May 2018