trialsTrialCompleted

Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer

A phase 3 trial of Bicalutamide, Flutamide, Goserelin / leuprolide, Buserelin, Triptorelin and Degarelix in Prostate cancer, run by Radiation Therapy Oncology Group, completed.

Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer is a phase 3 interventional study registered as NCT00936390 by Radiation Therapy Oncology Group, with 1538 participants recorded, started 2009-09 and reaching its primary completion in 2020-10-03. Interventions recorded: bicalutamide, flutamide, LHRH agonist (antagonist) therapy, Dose-Escalated Radiation Therapy. 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 Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer

Phase

Phase 3

Sponsor

Radiation Therapy Oncology Group

Registry

Started

2009-09

Reported

2022

Enrolled

1,538 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

1,538 enrolled

Percentage of Participants Alive (Overall Survival)primarysurvival endpoint

90 vs 91 out of 100 alive with Dose-Escalated Radiation Therapy Alone compared with Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation; 1 fewer per 100.
On this measure the first group did worse, not better.
Put another way, the treated group had about 15 percent lower chance of the event at any given time (hazard ratio 0.85, likely range 0.65 to 1.11).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
These results apply to the people the trial enrolled: A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer. 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.

1,538 enrolled.

Percentage of Participants Alive (Overall Survival)primary

HR 0.85 (0.65 to 1.11) · p = 0.22

Dose-Escalated Radiation Therapy Alone90 of 100

n = 750

Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation91 of 100

n = 742

Download

95% CI 87.7 to 92.2; Figures from the ClinicalTrials.gov results section (first posted 2022-10-06), not from a publication · 95% CI 88.8 to 93.1

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Percentage of Participants Alive (Overall Survival)primary	Dose-Escalated Radiation Therapy Alone	750	90%	0.85 (0.65 to 1.11)	0.22	link
Percentage of Participants Alive (Overall Survival)primary	Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation	742	91%	0.85 (0.65 to 1.11)	0.22	link

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cancers

Localised prostate cancer, intermediate risk Prostate cancer

drugs

ApprovedOral first-generation non-steroidal antiandrogen

Bicalutamide · Casodex

EstablishedGnRH agonist, injection or nasal spray

Buserelin · Suprefact

ApprovedGnRH antagonist depot

Degarelix · Firmagon

ApprovedNon-steroidal antiandrogen (first generation)

Flutamide · Eulexin (historic)

ApprovedGnRH agonist

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

ApprovedGnRH agonist depot

Triptorelin · Trelstar

companies