Status:
COMPLETED
Feasibility and Toxicity of Degarelix for Prostate Downsizing Prior to Permanent Seed Prostate Brachytherapy
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Prostate Cancer
Eligibility:
MALE
40-80 years
Phase:
PHASE2
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 ...
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 doc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01446991
Start Date
April 1 2012
End Date
December 1 2017
Last Update
January 27 2020
Active Locations (3)
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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