Reducing prostate cancer treatment from 5 to 3 doses of radiotherapy
The PRECISION Study: A Phase II Study of 3 Fractions of Prostate SBRT With RayPilot System and HypoCath Image Guidance for Men With NCCN Low or Intermediate Risk Prostate Cancer
This study is testing whether giving fewer doses of radiotherapy for early prostate cancer can still be just as effective and have fewer side effects for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | Male |
| Sponsor | NHS Lothian Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT06117059 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of reducing the number of curative radiotherapy doses for localized early prostate cancer from 5 to just 3, using Stereotactic Body Radiotherapy (SBRT). The aim is to ensure that the side effects of this 3-dose treatment are comparable to or lower than those observed in the 5-dose treatment from the UK PACE-B trial. Utilizing the RayPilot HypoCath tumor tracking system, which continuously monitors the prostate's position during treatment, the study seeks to enhance patient experience by minimizing treatment duration while maintaining efficacy. The study is a single-arm Phase II trial conducted at centers equipped with this advanced tracking technology.
Who should consider this trial
Good fit: Ideal candidates include men with low to favorable intermediate risk localized prostate cancer who meet specific health criteria.
Not a fit: Patients with advanced prostate cancer or those with certain health conditions that complicate treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the treatment burden for patients with localized prostate cancer while maintaining or improving quality of life.
How similar studies have performed: Previous studies have shown success with similar approaches to reducing treatment doses in prostate cancer, indicating potential for this method as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * low and favorable intermediate NCCN Criteria patients * Prostate volume under 80cc * IPSS under 20 * Q-max above 10cc per second and urinary residual less than 150mls * No TURP * No hip replacements * No previous radiotherapy to the pelvis * No active second malignancy except skin SCC or BCC for the last 2 years * No history of inflammatory bowel disease * No co-morbid illness that would make compliance to treatment difficult * Able to give informed consent Exclusion Criteria: * T3a or above * Gleason 4+3=7 * PSA\>20ng/ml
Where this trial is running
Edinburgh
- NHS Lothian — Edinburgh, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Duncan B McLaren, MBBS — NHS Lothian & University of Edinburgh
- Study coordinator: Richard Allan
- Email: richard.allan@nhslothian.scot.nhs.uk
- Phone: +44 1315371463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.