NCT06117059: PRECISION

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

Recruiting now NA Last updated 12 January 2026

What this trial tests

NA trial testing 3 fractions of prostate SBRT in Localized Prostate Cancer in 100 participants. Currently enrolling.

Timeline

1 November 2024

Primary endpoint
1 November 2026

1 November 2027

Quick facts

Lead sponsor	NHS Lothian
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 November 2024
Primary completion	1 November 2026
Estimated completion	1 November 2027
Sites	1 location across United Kingdom

Drugs / interventions tested

• 3 fractions of prostate SBRT

Conditions studied

• Localized Prostate Cancer — all drugs for Localized Prostate Cancer →
• Low Risk Prostate Cancer — all drugs for Low Risk Prostate Cancer →
• Intermediate Risk Prostate Cancer — all drugs for Intermediate Risk Prostate Cancer →

Sponsor

NHS Lothian — full company profile →

Who can join

Eligibility, male only, with Localized Prostate Cancer or Low Risk Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comprehensive one-day management of prostate cancer patients: PRO-FAST single-fraction ablative, urethral-sparing, HDR-like, robotic SBRT.
   Fodor A, Giannini L, Torrisi M, Brombin C, et al · · 2025 · PMID 40866948 · DOI 10.1186/s13014-025-02713-9