Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT00423475Other idGETUG-AFU 16 - UC-0160/0504Other idEUDRACT-2005-005165-11Other idCDR0000523446

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 743 participants (actual)
Sponsor: UNICANCER · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
France
Start: Oct 2006
Primary completion: Mar 2015
Completion: Not stated
First posted: 18 Jan 2007 (estimated)
Last update posted: 17 May 2018
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200620082010201220142016

Ph 3
Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer
NCT00423475
Oct 2006 to Mar 2015 (primary)

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

goserelin acetateDrug
adjuvant therapyProcedure
radiation therapyRadiation

Arms2

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
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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(6)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2019

1 result

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 et al. 2019The Lancet. Oncologycited by 190

PMID 31629656DOI 10.1016/s1470-2045(19)30486-3PUB-31629656

Full text at the publisher1 result

Publisher page See results (1)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2016

Corrected

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 et al. 2016The Lancet. Oncologycited by 272

PMID 27160475DOI 10.1016/s1470-2045(16)00111-xPUB-27160475

Full text at the publisher

Publisher page Read the notice

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedCampillo-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

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 120 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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