Trial details

Trial short name: PR.19

Official title: A Randomized Phase II Trial Evaluating Hight Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

Principal Investigator: Dr. Gerard Morton

Cancer type: Genitourinary
Cancer location: Prostate
Disease stage: Early Cancer
Trial phase: Phase 2
Intervention: Radiation Therapy: Brachytherapy

Registration #: NCT02960087

Trial description:
PATIENT ENROLLMENT FOR THIS TRIAL IS CURRENTLY ON HOLD DUE TO COVID-19 RESTRICTIONS The purpose of this study is to look at the effect of High Dose Rate (HDR) brachytherapy in patients with prostate cancer. Patients with low or intermediate risk prostate cancer that has been diagnosed in the last nine months may be able to participate. There will be two groups of patients participating in this study; one group will receive Low Dose Rate brachytherapy, a commonly used treatment, while the second group will receive the study treatment of High Dose Rate brachytherapy, another form of brachytherapy which delivers a high dose of radiation to the tumour over a period of minutes. Patients participating will know which treatment they receive but will be randomly allocated to one group or the other.

Inclusion Criteria: • 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). • Patients with low or intermediate risk prostate cancer are eligible according to the following guidelines: o TNM classification: - Clinical stage T1-T2 and Gleason 6 and PSA <20 ng/mL (Low risk) - Clinical stage T1-T2 and Gleason 7 (3+4) and PSA < 15 ng/mL and ≤ 50% of positive cores (Intermediate risk) • Eastern Cooperative Oncology Group status 0-1. • Bone scan and pelvic CT scan/MRI within the last 6 months at the discretion of the treating physician. • Patient must be ≥ 18 years of age. • Judged to be medically fit for brachytherapy. • Prostate volume by Trans-rectal Ultrasound (TRUS) or Magnetic Resonance Imaging (MRI) ≤ 60 cc within the last 6 months. • American Urological Association (AUA) score ≤ 20 (alpha blockers allowed) within the last 4 weeks. • Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French. • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate. • Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. • In accordance with CCTG policy, protocol treatment is to begin within 8 weeks of patient randomization. • Patients must be willing to take precautions to prevent pregnancy while on study. 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 (ADT). • Alpha-reductase inhibitors (ARIs) within 90 days of randomization. • Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior 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).