RecruitingNot ApplicableNCT06117059

The PRECISION Study: 3 Fractions of Prostate SBRT and RayPilot HypoCath Image Guidance

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


Sponsor

NHS Lothian

Enrollment

100 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators want to investigate whether it is possible to reduce the number of curative radiotherapy doses from 5 to only 3 for men with localized early prostate cancer. The aim of the study is to ensure that the side effects of the 3-dose treatment are the same or potentially lower than those already published when using the 5-dose treatment as used in the UK PACE-B trial (NCT01584258). The name of this type of radiotherapy is Stereotactic Body Radiotherapy (SBRT) or participants may see it referred to as Stereotactic Ablative Radiotherapy (SABR). The study is a two-stage single arm Phase II study open to those Centres that use the RayPilot HypoCath tumour tracking system (Micropos Medical). This commercially available system was not available at the time of the original PACE-B study. The system acts like a Global Positioning Device (GPS) to continuously track the prostate position during radiotherapy. If the prostate moves more than 2mm (about 0.08 in) from its intended position during the treatment, then the radiotherapy team are alerted, and the treatment halted until the prostate moves back into the correct position. The ability to understand exactly where the prostate is throughout the treatment ensures the intended dose hits the cancer and does not accidentally increase the dose to the nearby bladder and rectum. The system is a modification of a standard urinary catheter which sits within the bladder with the GPS placed within the wall of the catheter as it passes through the prostate. The investigators are not testing the system as it is commercially available but using it to improve the accuracy of radiotherapy delivery, reducing the number of days of treatment, minimizing side effects and helping ease the burden on busy radiotherapy Departments.


Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study (PRECISION) tests a form of high-precision radiation therapy called SBRT (stereotactic body radiotherapy) delivered in just 3 treatment sessions for prostate cancer, guided by an advanced real-time tracking device (RayPilot HypoCath). Fewer treatment sessions with high accuracy may offer a more convenient option for patients. **You may be eligible if:** - You have low-risk or favorable intermediate-risk prostate cancer (by NCCN guidelines) - Your prostate volume is under 80cc - Your urinary symptom score (IPSS) is below 20 - Your urine flow is adequate (Q-max above 10 cc/sec) - You have no history of pelvic radiation or inflammatory bowel disease - You have no hip replacements **You may NOT be eligible if:** - Your cancer has spread beyond the prostate (T3a or higher) - Your Gleason score is 4+3=7 (a higher-risk cancer grade) - Your PSA is above 20 ng/mL - You have had a TURP (prostate surgery) or prior pelvic radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATION3 fractions of prostate SBRT

Radical radiotherapy using only 3 fractions of prostate SBRT over 3 consecutive days


Locations(1)

NHS Lothian

Edinburgh, United Kingdom

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NCT06117059


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