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


Phase 2
40 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.


Inclusion Criteria:



- Histologic diagnosis of prostate cancer

- Favorable risk disease (cT1 or T2a, Gleason score (GS) 6, and 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

prostate volume reduction

Outcome Description:

determined by transrectal ultrasound with planimetry volume calculation

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Juanita M Crook, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

Canada: Institutional Review Board

Study ID:

H11-08172

NCT ID:

NCT01446991

Start Date:

April 2012

Completion Date:

October 2014

Related Keywords:

  • Prostate Cancer
  • prostate neoplasm
  • brachytherapy
  • androgen ablation
  • benign prostatic hypertrophy
  • prostate size reduction
  • localized prostate cancer with prostate volume > 40 cc
  • Prostatic Neoplasms

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