trialsTrialCompleted

Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer

A phase 3 trial of Degarelix, Goserelin / leuprolide and Bicalutamide in Prostate cancer, run by Ferring Pharmaceuticals, completed.

Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer is a phase 3 interventional study registered as NCT00833248 by Ferring Pharmaceuticals, with 246 participants recorded, started 2009-04 and reaching its primary completion in 2011-09. Interventions recorded: Degarelix, Goserelin, Bicalutamide. Conditions recorded: Prostate Cancer.

Linked to the drug Degarelix 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 Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)

Phase

Phase 3

Sponsor

Ferring Pharmaceuticals

Registry

Started

2009-04

Reported

2012

Enrolled

246 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

246 enrolled

Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)primaryother endpoint

Degarelix 240 mg/80 mg: -36 milliliter; Goserelin (3.6 mg) + Bicalutamide (50 mg): -35.3 milliliter.

The p-value (0.8942) means the difference could plausibly be due to chance.
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 Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent). 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.

246 enrolled.

Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)primary

· p = 0.8942

Download

SD 14.5; Figures from the ClinicalTrials.gov results section (first posted 2012-09-27), not from a publication · SD 16.7

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)primary	Degarelix 240 mg/80 mg	176	-36 milliliter	-	0.8942	link
	Goserelin (3.6 mg) + Bicalutamide (50 mg)	62	-35.3 milliliter	-	0.8942	link

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cancers

Prostate cancer

drugs

ApprovedOral first-generation non-steroidal antiandrogen

Bicalutamide · Casodex

ApprovedGnRH antagonist depot

Degarelix · Firmagon

ApprovedGnRH agonist

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

companies

Ferring Pharmaceuticals