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


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01446991

Sponsor: British Columbia Cancer Agency

Phase: Phase 2

Eligibility:

  • Age: minimum 40 Years maximum 80 Years
  • Gender: Male

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

View trial on ClinicalTrials.gov