Phase III Randomized Comparison of LDR vs. HDR Brachytherapy for Low and Intermediate Risk Prostate Cancer

Official Title

A Phase III Randomized Study of Low Dose Rate Compared to High Dose Rate Prostate Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer

Summary:

H17-02904 is a randomized comparison of low dose rate vs. high dose rate prostate brachytherapy for favourable and intermediate risk prostate cancer suitable for brachytherapy as monotherapy. This is a continuation with expanded accrual of the randomized Pilot study H15-02103

Trial Description

Primary Outcome:

• The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.

Secondary Outcome:

• Quality of Life in the bowel and sexual domains
• Time to return to baseline +/- 3 points for the International Prostate Symptom Score
• Acute and long term toxicity
• Biochemical Outcome
• Histologic Outcome
• Cell cycle progression score
• Tumour oxygenation and cell cycle distribution

Men suitable for prostate brachytherapy as monotherapy will undergo multiparametric Magnetic Resonance Imaging for staging and identification of a dominant lesion and will be randomly selected for either a single low dose rate permanent seed implant or 2 fractions of high dose rate brachytherapy. Using image registration techniques, dominant lesions will be biopsied under anesthesia at the start of the brachytherapy procedure. Biopsies will reviewed for tumour Gleason score and sent for Cell Cycle Progression testing (Prolaris). Patients receiving high dose rate brachytherapy will also have biopsies between the 2 fractions to assess tumour changes induced from the first fraction. Post implant quality assurance will determine the dose to the dominant lesions and compare these between the 2 types of brachytherapy. Post implant symptoms will be tracked for severity and time course.

View this trial on ClinicalTrials.gov