A Phase II Randomized Trial Evaluating Acute and Late Toxicity of High-Dose Rate Brachytherapy and Low-Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02628041

Sponsor: CHU de Quebec-Universite Laval

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. -Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the

Eligibility Criteria:

  • and have a recent prostate biopsy (within 9 months).
  • Low-risk disease defined as: Clinical stage T1-T2 and Gleason 6 and PSA≤20 ng/mL.
  • Intermediate-risk disease defined as: Clinical stage T1-T2 and Gleason 7 (3+4) and PSA ≤ 20 ng/mL and ≤ 60% of positive cores.
  • Lymph node evaluation by either CT or MRI is optional and is left at the discretion of the treating physician.
  • No alpha reductase inhibitors use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization.
  • Eastern Cooperative Oncology Group status 0-1
  • No hormonal therapy is accepted.
  • Prostate volume by Trans-rectal Ultrasound (TRUS) ≤ 60 cc.
  • Internation Prostate Symptom Score (IPSS) ≤ 20 (alpha blockers allowed)

Exclusion Criteria:

  • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
  • Prior or current bleeding diathesis
  • Previous androgen deprivation therapy within 6 months of the registration.
  • Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior Transurethral resection of the prostate (TURP), prior cryosurgery of the prostate.
  • Evidence of metastatic disease (radiology investigations at the discretion of the treating physician).
  • Any serious active or co-morbid medical conditions, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).
  • Gleason score 7 (4+3), clinical stage≥ T3a, PSA > 20 and > 60% of positive cores.

View trial on ClinicalTrials.gov