trialsTrialPositive

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

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.

Also called: SPPORTNRG Oncology RTOG 0534

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.

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

Phase

Phase 3

Sponsor

Radiation Therapy Oncology Group

Registry

NCT00567580

Headline 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.

Started

2008-02

Reported

2022

Enrolled

1,792 enrolled

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.

Outcomes

2top

In plain words

What these results mean for people, not percentages

1,792 enrolled

Freedom from progression at 5 yearsprimaryother endpoint

70.9 vs 81.3 out of 100 reached this endpoint at 5 years with Prostate bed radiotherapy alone compared with Prostate bed radiotherapy with short-term androgen deprivation; 10.4 fewer per 100.
On this measure the first group did worse, not better.
Other groups: Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation 87.4 of 100.

Acute grade 2 or worse adverse events within 3 monthsother endpoint

18 vs 36 out of 100 reached this endpoint with Prostate bed radiotherapy alone compared with Prostate bed radiotherapy with short-term androgen deprivation; 18 fewer per 100.
Roughly one extra person helped for every 6 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Other groups: Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation 44 of 100.

Caveats

This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
These results apply to the people the trial enrolled: 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. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

1,792 enrolled.

Freedom from progression at 5 yearsprimary

Prostate bed radiotherapy alone70.9 of 100

n = 592

Prostate bed radiotherapy with short-term androgen deprivation81.3 of 100

n = 602

Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation87.4 of 100

n = 598

Download

Analysed in 1,716 eligible men at a median 8.2 years among survivors; group 3 was superior to groups 1 and 2 per protocol.

Source

Acute grade 2 or worse adverse events within 3 months

Prostate bed radiotherapy alone18 of 100

n = 547

Prostate bed radiotherapy with short-term androgen deprivation36 of 100

n = 563

Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation44 of 100

n = 563

Download

Group 3 against group 2 p=0.0034; group 2 against group 1 p<0.0001.

Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Freedom from progression at 5 yearsprimary	Prostate bed radiotherapy alone	592	70.9%	-	-	link
	Prostate bed radiotherapy with short-term androgen deprivation	602	81.3%
	Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation	598	87.4%
Acute grade 2 or worse adverse events within 3 months	Prostate bed radiotherapy alone	547	18%	-	-	link
	Prostate bed radiotherapy with short-term androgen deprivation	563	36%
	Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation	563	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

top

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).

Connected

11top

Trial
Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer
Shares Buserelin, Flutamide, Triptorelin, Bicalutamide and the tag pipeline.
Trial
Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer
Shares Buserelin, Flutamide, Bicalutamide, Goserelin / leuprolide (ovarian function suppression) and the tag pipeline.
Trial
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial
Shares Buserelin, Flutamide, Triptorelin, Bicalutamide and the tag pipeline.
Trial
Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer
Shares Buserelin, Flutamide, Bicalutamide, Goserelin / leuprolide (ovarian function suppression) and the tag pipeline.
Trial
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
Shares Flutamide, Triptorelin, Bicalutamide, Goserelin / leuprolide (ovarian function suppression) and the tag pipeline.
Trial
Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
Shares Flutamide, Bicalutamide, NRG Oncology, Prostate cancer and the tag pipeline.
Trial
Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
Shares Flutamide, Triptorelin, Prostate cancer and the tag pipeline.
Trial
Flutamide, Suramin, and Hydrocortisone in Treating Patients With Prostate Cancer
Shares Flutamide, Goserelin / leuprolide (ovarian function suppression), Prostate cancer and the tag pipeline.

cancers

Biochemical recurrence of prostate cancer Prostate cancer

drugs

ApprovedOral first-generation non-steroidal antiandrogen

Bicalutamide · Casodex

EstablishedGnRH agonist, injection or nasal spray

Buserelin · Suprefact

ApprovedNon-steroidal antiandrogen (first generation)

Flutamide · Eulexin (historic)

ApprovedGnRH agonist

Goserelin / leuprolide (ovarian function suppression) · Zoladex; Lupron

ApprovedGnRH agonist depot

Triptorelin · Trelstar

companies

NRG Oncology

trials

GETUG-AFU 16 RADICALS-HD RTOG 9601

Evidence strength90/100 · Strong

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
1,792 enrolled+16
Primary endpoint: time to progression or recurrence+14
Result: positive+15
Independent replication or consistent trials+10
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 5 drugs · diff · file

Sources & links

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

Also called: SPPORTNRG Oncology RTOG 0534

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.

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

Phase

Phase 3

Sponsor

Radiation Therapy Oncology Group

Registry

NCT00567580

Headline result

Started

2008-02

Reported

2022

Enrolled

1,792 enrolled

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.

Outcomes

2top

In plain words

What these results mean for people, not percentages

1,792 enrolled

Freedom from progression at 5 yearsprimaryother endpoint

70.9 vs 81.3 out of 100 reached this endpoint at 5 years with Prostate bed radiotherapy alone compared with Prostate bed radiotherapy with short-term androgen deprivation; 10.4 fewer per 100.
On this measure the first group did worse, not better.
Other groups: Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation 87.4 of 100.

Acute grade 2 or worse adverse events within 3 monthsother endpoint

18 vs 36 out of 100 reached this endpoint with Prostate bed radiotherapy alone compared with Prostate bed radiotherapy with short-term androgen deprivation; 18 fewer per 100.
Roughly one extra person helped for every 6 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Other groups: Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation 44 of 100.

Caveats

This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
These results apply to the people the trial enrolled: 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. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

1,792 enrolled.

Freedom from progression at 5 yearsprimary

Prostate bed radiotherapy alone70.9 of 100

n = 592

Prostate bed radiotherapy with short-term androgen deprivation81.3 of 100

n = 602

Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation87.4 of 100

n = 598

Download

Analysed in 1,716 eligible men at a median 8.2 years among survivors; group 3 was superior to groups 1 and 2 per protocol.

Source

Acute grade 2 or worse adverse events within 3 months

Prostate bed radiotherapy alone18 of 100

n = 547

Prostate bed radiotherapy with short-term androgen deprivation36 of 100

n = 563

Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation44 of 100

n = 563

Download

Group 3 against group 2 p=0.0034; group 2 against group 1 p<0.0001.

Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Freedom from progression at 5 yearsprimary	Prostate bed radiotherapy alone	592	70.9%	-	-	link
	Prostate bed radiotherapy with short-term androgen deprivation	602	81.3%
	Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation	598	87.4%
Acute grade 2 or worse adverse events within 3 months	Prostate bed radiotherapy alone	547	18%	-	-	link
	Prostate bed radiotherapy with short-term androgen deprivation	563	36%
	Pelvic nodal and prostate bed radiotherapy with short-term androgen deprivation	563	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

top

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).

Connected

11top

Trial
Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer
Shares Buserelin, Flutamide, Triptorelin, Bicalutamide and the tag pipeline.
Trial
Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer
Shares Buserelin, Flutamide, Bicalutamide, Goserelin / leuprolide (ovarian function suppression) and the tag pipeline.
Trial
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial
Shares Buserelin, Flutamide, Triptorelin, Bicalutamide and the tag pipeline.
Trial
Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer
Shares Buserelin, Flutamide, Bicalutamide, Goserelin / leuprolide (ovarian function suppression) and the tag pipeline.
Trial
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
Shares Flutamide, Triptorelin, Bicalutamide, Goserelin / leuprolide (ovarian function suppression) and the tag pipeline.
Trial
Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
Shares Flutamide, Bicalutamide, NRG Oncology, Prostate cancer and the tag pipeline.
Trial
Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer
Shares Flutamide, Triptorelin, Prostate cancer and the tag pipeline.
Trial
Flutamide, Suramin, and Hydrocortisone in Treating Patients With Prostate Cancer
Shares Flutamide, Goserelin / leuprolide (ovarian function suppression), Prostate cancer and the tag pipeline.

cancers

Biochemical recurrence of prostate cancer Prostate cancer

drugs

ApprovedOral first-generation non-steroidal antiandrogen

Bicalutamide · Casodex

EstablishedGnRH agonist, injection or nasal spray

Buserelin · Suprefact

ApprovedNon-steroidal antiandrogen (first generation)

Flutamide · Eulexin (historic)

ApprovedGnRH agonist

Goserelin / leuprolide (ovarian function suppression) · Zoladex; Lupron

ApprovedGnRH agonist depot

Triptorelin · Trelstar

companies

NRG Oncology

trials

GETUG-AFU 16 RADICALS-HD RTOG 9601

Evidence strength90/100 · Strong

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
1,792 enrolled+16
Primary endpoint: time to progression or recurrence+14
Result: positive+15
Independent replication or consistent trials+10
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 5 drugs · diff · file

Sources & links

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

Outcomes

Notes

Connected

Similar pages

cancers

drugs

companies

trials

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

Outcomes

Notes

Connected

Similar pages

cancers

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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

Overview

Outcomes

Notes

Connected

Similar pages

cancers

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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

Overview

Outcomes

Notes

Connected

Similar pages

cancers

drugs

companies

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