Focal Low Dose Rate ( LDR) Brachytherapy: Hemi-ablative Treatment With LDR for Patients With Low and Low-tier Intermediate Risk Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02643511

Sponsor: St George Hospital, Australia

Phase: Phase 2

Eligibility:

  • Age: minimum 60 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 1. Patients must have histologically proven adenocarcinoma of the prostate. 2. Patients must have low or low-tier intermediate prostate cancer
  • Low risk prostate cancer patients must have:
  • Clinical stage ≤ T2a,
  • Gleason score =6 and iPSA ≤ 10 ng/ml
  • < 25% cores positive, < 50 % cancer in each core involved
  • Low tier Intermediate risk patients may have:
  • Clinical stageT2a
  • Gleason score ≤ 3+4=7
  • PSA ≤ 10 ng/ml
  • < 25% cores positive, < 50 % cancer in each core 3. Patients must be fit for general anesthetic. 4. Patients must have unilateral disease on biopsy 5. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0
  • 2. 6. Men ≥ 65 years of age with a life expectancy estimated to be >10 years. 7. Patients must have no contraindications to interstitial prostate brachytherapy. 8. Patients on anticoagulant therapy must be able to stop therapy safely for at least 7 days. 9. Patients must not have any contraindications to MRI 10. IPSS <=16

Exclusion Criteria:

  1. Does not meet staging criteria for low risk or low tier intermediate risk prostate cancer
  2. Bilateral prostatic disease
  3. Prior hormonal therapy
  4. Prior Transurethral resection or middle lobe resection
  5. Recent IPSS>
  6. Unfit for general anesthetic
  7. MRI contraindicated
  8. Unable to cease anticoagulant therapy
  9. Life expectancy < 10 years
  10. IPSS>16

View trial on ClinicalTrials.gov


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