Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate Brachytherapy

Prostate Cancer Clinical Trial

Official title:

Phase II Trial Assessing the Feasibility and Toxicity of Degarelix in Achieving Prostate Downsizing Prior to Treatment With Permanent Seed Prostate Brachytherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446991
• Other study ID #: H11-08172
• Status: Completed
• Phase: Phase 2
• Start date: April 2012
• Est. completion date: December 2017

Study information

• Verified date: January 2020
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the efficacy of Degarelix, a Luteinizing Hormone Releasing Hormone (LHRH) antagonist, to reduce prostate volume prior to permanent seed prostate brachytherapy. There are 2 eligible populations of men, all of whom will have selected brachytherapy as their treatment of choice for their prostate cancer. Either they have an enlarged prostate that requires size reduction to render brachytherapy technically feasible, or they require androgen ablation in conjunction with brachytherapy for optimal tumor control. The hypothesis is that Degarelix will provide > 30% volume reduction by 3 months in > 30% of men.

Description:

All men will have a baseline transrectal ultrasound for brachytherapy planning that has demonstrated an enlarged prostate with or without pubic arch obstruction. After signing the informed consent document they will have a loading dose of 240 mg Degarelix and then monthly maintenance dose injections of 80 mg until such time as sufficient prostate reduction has occured (2-3 months) or they complete the 6 months of required androgen ablation for their disease status.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Histologic diagnosis of prostate cancer

• Favorable risk disease (cT1 or T2a, Gleason score (GS) 6, and Prostate Specific Antigen (PSA) < 10 ng/mL)

• Low-tier intermediate risk disease (cT2c,GS=6,and PSA 10-15 ng/mL, OR GS=7 and PSA < 10 ng/mL)

• Intermediate risk disease AND androgen deprivation therapy recommended by the treating physician for oncologic reasons such as (= 50% positive biopsy cores,cT2c,PSA 15-20 ng/mL,GS=7)

• Patient requires baseline planning trans-rectal ultrasound for the purposes of prostate brachytherapy, showing prostate volume > 40 mL and pubic arch interference (not required for those requiring androgen ablation for oncologic reasons)

Exclusion Criteria:

• castrate serum testosterone level

• previous or concurrent pelvic radiotherapy

• unable to give written informed consent

• contraindications to permanent seed prostate brachytherapy or to androgen deprivation therapy

• prior treatment for prostate cancer

• prior trans-urethral resection of the prostate

• previous therapy with a 5-a reductase inhibitor, anti-androgen agent, or LHRH agonist

• previous therapy with degarelix

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
240 mg loading dose followed by monthly 80 mg maintenance dose for 2-3 months
• Degarelix
240 mg loading dose of Degarelix followed by 80 mg maintenance doses every month for a total duration of 6 months.

Locations

Country	Name	City	State
Canada	Abbottsford Cancer Center	Abbottsford	British Columbia
Canada	Fraser Valley Cancer Center	Surrey	British Columbia
Canada	Vancouver Cancer Center	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prostate volume reduction	determined by transrectal ultrasound with planimetry volume calculation	3 months
Secondary	testosterone recovery	Luteinizing Hormone(LH), Follicle Stimulating Hormone (FSH) and testosterone will be measured at 1, 3, 6, 9 and 12 months following cessation of Degarelix.	12 months