Reboot Rx, a nonprofit focused on advancing affordable cancer treatments by repurposing generic drugs, today released its first online resource for clinicians, designed to make information on low-cost treatment approaches easier to find and evaluate. The initial release summarizes evidence on the use of 5-alpha reductase inhibitors (5-ARIs) for patients with prostate cancer on active surveillance. Clinicians can explore the new 5-ARI resource at www.rebootrx.org/prostate/5-aris/. 

A Gap in Evidence Evaluation and Visibility

Many FDA-approved generic drugs have been studied for uses outside their labeled indications, including for potential benefits in cancer treatment. But due to a lack of incentives, including those related to patent expiration, the traditional drug development model is not structured to support further research, evidence dissemination, or FDA review for these other uses. Reboot Rx was founded to help address this gap and improve access to data and information for clinicians, health systems, and other decision-makers.

“Clinicians face an overwhelming amount of literature, and important evidence on low-cost cancer treatments can be difficult to find,” said Laura Kleiman, PhD, Founder and CEO of Reboot Rx. “We gather publicly available data, consult with experts, and provide information to clinicians, making it easier for them to assess treatment options for their patients.”

Reboot Rx examined repurposing opportunities in prostate cancer through a comprehensive evaluation that combined internally developed AI tools with manual review and input from clinical experts. The process included analyzing more than 16,000 published articles in which 90 drug products approved for non-cancer indications were studied in prostate cancer. Within this body of literature, 5-ARIs stood out as an area with a developed evidence base.

5-ARIs: An Important Area for Evidence Synthesis

5-ARIs—finasteride and dutasteride—inhibit the 5-alpha reductase enzyme and reduce levels of dihydrotestosterone. They are FDA-approved for the treatment of benign prostatic hyperplasia (finasteride and dutasteride) and androgenetic alopecia (finasteride). These generic, oral medications are widely available and often cost under $10 per month. 

5-ARIs have been studied for potential benefits among patients with prostate cancer on active surveillance, particularly those with low-risk and select favorable intermediate-risk disease, though they are not approved for this indication. While active surveillance is appropriate for many patients, some ultimately transition to surgery or radiation, which can carry risks such as urinary, sexual, and bowel side effects. Over the past two decades, two randomized controlled trials, 10 observational studies, and three meta-analyses have examined 5-ARIs for slowing progression and extending time on active surveillance for appropriately selected patients. 

Studies have re-examined earlier concerns that led to an FDA warning in product labeling regarding a potential increased risk of high-grade prostate cancer associated with 5-ARI use. Some analyses suggest that observed differences may have been influenced by a detection bias. The FDA has not endorsed these analyses, and the warning remains in place.

A Central Resource for Clinicians

The new 5-ARI online resource developed by Reboot Rx consolidates publicly available information, including evidence from published clinical studies, safety considerations, mechanism of action, and drug access. Detailed study summaries, references, and supporting materials are available, and the resource will be updated as new information emerges.

“Reboot Rx's systematic approach has surfaced overlooked data and information that are worthy of evaluation when considering 5-ARIs as a possible treatment option,” said Ian M. Thompson Jr., MD, Professor Emeritus and former Chair of Urology at UT Health San Antonio. “Their robust collection of safety and efficacy data makes it easier for clinicians to review the totality of existing evidence and consider how 5-ARIs may fit as an adjunct within their management of patients on active surveillance.”