# Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer

Source: https://onco.cc/trials/nct00567580/  
OnCo record `nct00567580` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Flutamide, Bicalutamide, Goserelin / leuprolide, Buserelin and Triptorelin in Prostate cancer, run by Radiation Therapy Oncology Group, with a status the registry has not verified recently.

## Summary

Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer is a phase 3 interventional study registered as NCT00567580 by Radiation Therapy Oncology Group, with 1792 participants planned, started 2008-02 and due to reach its primary completion in 2018-07-12. Interventions recorded: PBRT, PLNRT, AA, LHRH agonist. Conditions recorded: Prostate Cancer.

Linked to the drug Buserelin because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-22
- Also known as: SPPORT; NRG Oncology RTOG 0534
- Tags: pipeline; ctgov-ingest
- Registry id: NCT00567580
- Phase: 3
- Setting: 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
- Sponsor: Radiation Therapy Oncology Group
- Enrolled: 1792
- Result: Five-year freedom from progression after prostatectomy 70.9 percent with prostate bed radiotherapy alone, 81.3 percent with added short-term androgen deprivation and 87.4 percent with pelvic nodal radiotherapy as well.
- Outcomes: Freedom from progression at 5 years: Prostate bed radiotherapy alone 70.9% vs Prostate bed radiotherapy with short-term androgen deprivation 81.3% vs Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation 87.4%; Acute grade 2 or worse adverse events within 3 months: Prostate bed radiotherapy alone 18% vs Prostate bed radiotherapy with short-term androgen deprivation 36% vs Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation 44%
- Replication: GETUG-AFU 16 showed the androgen deprivation component independently, raising 120-month progression-free survival from 49 to 64 percent with 6 months of goserelin.

## Notes

- SPPORT was run at 283 radiation oncology centres in the United States, Canada and Israel between 31 March 2008 and 30 March 2015, enrolling men with a persistently detectable or initially undetectable and rising PSA of 0.1 to 2.0 ng/mL after prostatectomy, pT2 or pT3 disease and a Gleason score of 9 or less. Prostate bed radiotherapy was 64.8 to 70.2 Gy at 1.8 Gy per fraction; pelvic nodal radiotherapy was 45 Gy at 1.8 Gy per fraction before a volume reduction for the remaining 19.8 to 25.2 Gy. Of 1,792 enrolled men, 76 were later found ineligible, leaving 1,716 evaluable.

At the interim analysis of 1,191 men the Haybittle-Peto boundary of p<0.001 was exceeded comparing group 1 with group 3 (difference 17.9 percent, standard error 2.9, p<0.0001); the difference between groups 2 and 3 did not exceed the boundary (p=0.0063). Late toxicity beyond 3 months did not differ significantly between groups, apart from more late grade 2 or worse blood or bone marrow events in group 3 than group 2 (one-sided p=0.0060), attributable to the nodal radiotherapy (Lancet 2022).

## Sources

- ClinicalTrials.gov NCT00567580: https://clinicaltrials.gov/study/NCT00567580
- SPPORT / NRG Oncology RTOG 0534 (Lancet 2022): https://doi.org/10.1016/S0140-6736(21)01790-6

## Connected records

- cancers: [Biochemical recurrence of prostate cancer](https://onco.cc/cancers/prostate-bcr/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- drugs: [Bicalutamide](https://onco.cc/drugs/bicalutamide/), [Buserelin](https://onco.cc/drugs/buserelin/), [Flutamide](https://onco.cc/drugs/flutamide/), [Goserelin / leuprolide (ovarian function suppression)](https://onco.cc/drugs/goserelin/), [Triptorelin](https://onco.cc/drugs/triptorelin/)
- companies: [NRG Oncology](https://onco.cc/companies/nrg-oncology/)
- trials: [GETUG-AFU 16](https://onco.cc/trials/getug-afu-16/), [RADICALS-HD](https://onco.cc/trials/radicals-hd/), [RTOG 9601](https://onco.cc/trials/rtog-9601/)

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