CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 1,792 enrolled
Drug / intervention
AA +3 moredrug
Likely dose
AA 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00567580
NCT00567580Phase 3Active
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A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy

Radiation Therapy Oncology Group·interventional·Posted Dec 5, 2007·Updated May 9, 2025

In Brief

A Phase 3 clinical trial evaluating PBRT, PLNRT, and 2 other interventions for Prostate Cancer. Active but no longer recruiting, targeting 1,792 participants across 460 sites in 4 countries.

Detailed 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 flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen-deprivation therapy is more effective for prostate cancer. PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCanada, China, Israel, United States
CollaboratorsNational Cancer Institute (NCI), Cancer and Leukemia Group B, NRG Oncology

Timeline

Phase 3ActiveOverdue
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2007
Enrollment StartFeb 1, 2008
Primary CompletionJul 12, 2018
TodayJul 2, 2026
Enrollment to primary: 10.4 yearsPosted 18.6 years ago

Interventions

PBRTradiation

1.8 Gy per fraction once daily, 5 days a week totaling 64.8-70.2 Gy. 3D-CRT or IMRT required.

PLNRTradiation

1.8 Gy per fraction once daily, 5 days a week, totaling 45 Gy. 3D-CRT or IMRT required.

AAdrug

Antiandrogen (AA) therapy can be either 250 mg flutamide by mouth three times a day or 50 mg bicalutamide by mouth once a day.

LHRH agonistdrug

Luteinizing hormone-releasing hormone (LHRH) agonist can be any analog approved by the FDA (or by Health Canada for Canadian institutions) and may be given in any possible combination such that the total LHRH treatment time is 4-6 months. LHRH analogs are administered with a variety of techniques, including subcutaneous insertion of a solid plug in the abdominal wall, intramuscular injection, and subcutaneous injection.