June 1, 2016. PRECISE-a new Phase III clinical trial, will examine whether magnetic resonance imaging (MRI) can supplant the existing standard of care used to detect prostate cancer. The chief objective of the multi-center trial-supported by the Ontario Institute for Cancer Research (OICR), Prostate Cancer Canada, and the Movember Foundation- is to define whether MRI can prevent some men from requiring a biopsy and to circumvent the possible associated side effects, if a biopsy is required.
The trial will be conducted by Dr. Laurence Klotz, of the Sunnybrook Research Institute in Toronto, with an initial funding of $3 million.
The Ontario Clinical Oncology Group (OCOG) in the Escarpment Cancer Research Institute, a Hamilton Health Sciences and McMaster University Institute, will lead data management and analysis for the trial. Director of OCOG, Dr. Mark Levine, shares that, “we are excited about collaborating with Dr. Klotz on the evaluation of this innovative technology which could potentially impact the lives of thousands of Canadian men”.
The PRECISE trial, projected for completion in three years time, will consider the ability of MRI to improve diagnosis and reduce the requirement for prostate biopsies. MRI technology is a precise tool that could better detect which patients should undergo a biopsy, and enable focused biopsy of only areas suspected of malignancy.
At present, we detect prostate cancer using trans-rectal ultrasound (TRUS)-guided biopsy of the prostate, in most circumstances after a prostate specific antigen (PSA) test. TRUS-guided biopsy is associated with possible side effects such as infection and bleeding because it is not targeted, requiring numerous biopsy samples (between 10 and 12) to establish a correct analysis. In addition, this existing standard of care is not sensitive enough to be able to distinguish between high-risk and very low-risk changes in prostate tissue, resulting in the over-diagnosis and over-treatment of many men, exacerbating the risk for side effects.
“If positive, this trial would support a transformation in practice from relying on biopsies for all men with suspected prostate cancer to providing MRI first with selective targeted biopsy,” Dr Klotz explains. “This would allow 250,000 men per year in the U.S. and Canada to avoid unnecessary biopsies and the associated complications including hospitalization, without compromising our ability to identify clinically significant cancers.”