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

Sponsor

British Columbia Cancer Agency (Other)

Overall Status

Completed

CT.gov ID

NCT01446991

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

16.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Degarelix Drug: Degarelix	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Favorable prostate cancer with pubic arch interference Men in this arm have chosen brachytherapy for management of localized prostate cancer and do not require androgen ablation for oncologic reasons but have an enlarged prostate causing pubic arch interference and thus require prostate size reduction prior to brachytherapy. They will have 2-3 months of Degarelix with measurement of prostate volume at 8 and 12 weeks.	Drug: Degarelix 240 mg loading dose followed by monthly 80 mg maintenance dose for 2-3 months
Experimental: Intermediate risk prostate cancer, 6 months Degarelix Men in this arm have higher risk prostate cancer (upper tier intermediate risk by National Comprehensive Cancer Network [NCCN] guidelines) and require 6 months of androgen ablation in conjunction with brachytherapy. Prostate size must be > 40 cc at baseline so that prostate size reduction measurements are appropriate. Prostate measurements by transrectal ultrasound with be taken at 12 weeks and 20 weeks.	Drug: Degarelix 240 mg loading dose of Degarelix followed by 80 mg maintenance doses every month for a total duration of 6 months.

Arm

Intervention/Treatment

Experimental: Favorable prostate cancer with pubic arch interference

Men in this arm have chosen brachytherapy for management of localized prostate cancer and do not require androgen ablation for oncologic reasons but have an enlarged prostate causing pubic arch interference and thus require prostate size reduction prior to brachytherapy. They will have 2-3 months of Degarelix with measurement of prostate volume at 8 and 12 weeks.

Drug: Degarelix

240 mg loading dose followed by monthly 80 mg maintenance dose for 2-3 months

Experimental: Intermediate risk prostate cancer, 6 months Degarelix

Men in this arm have higher risk prostate cancer (upper tier intermediate risk by National Comprehensive Cancer Network [NCCN] guidelines) and require 6 months of androgen ablation in conjunction with brachytherapy. Prostate size must be > 40 cc at baseline so that prostate size reduction measurements are appropriate. Prostate measurements by transrectal ultrasound with be taken at 12 weeks and 20 weeks.

Drug: Degarelix

240 mg loading dose of Degarelix followed by 80 mg maintenance doses every month for a total duration of 6 months.

Outcome Measures

Primary Outcome Measures

prostate volume reduction [3 months]
determined by transrectal ultrasound with planimetry volume calculation

Secondary Outcome Measures

testosterone recovery [12 months]
Luteinizing Hormone(LH), Follicle Stimulating Hormone (FSH) and testosterone will be measured at 1, 3, 6, 9 and 12 months following cessation of Degarelix.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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-α reductase inhibitor, anti-androgen agent, or LHRH agonist
previous therapy with degarelix

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abbottsford Cancer Center	Abbottsford	British Columbia	Canada
2	Fraser Valley Cancer Center	Surrey	British Columbia	Canada
3	Vancouver Cancer Center	Vancouver	British Columbia	Canada	V5Z4E6