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

NCT06117059 | Recruiting DMC

• 1 other identifier: AC23118
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Localized Prostate Cancer; Low Risk Prostate Cancer; Intermediate Risk Prostate Cancer

Keywords

SBRT; SABR; PROSTATE CANCER; RayPilot; HypoCath; Continuous tracking; 3 fractions

Outcome Measures

Primary Outcomes (4)

• The number of patients with acute Radiation Oncology/ Toxicity Grading (RTOG) urinary toxicity

  Clinician reported cumulative Grade 2 or worse RTOG acute GU toxicity from baseline up to 12 weeks post treatment (scale 0-4 with 0 being none increasing severity to grade 4).

  At 12 weeks post completion of treatment

• The number of patients with acute Common Terminology for Adverse Events (CTCAE) urinary toxicity

  Clinician reported cumulative Grade 2 or worse CTCAE v5.0 acute GU toxicity from baseline up to 12 weeks post treatment (scale 0-5 with increasing severity to death at grade 5)

  At 12 weeks post completion of treatment

• The number of patients with acute Radiation Oncology/ Toxicity Grading (RTOG) bowel toxicity

  Clinician reported cumulative Grade 2 or worse RTOG acute GI toxicity from baseline up to 12 weeks post treatment (scale 0-4 with 0 being none increasing severity to grade 4).

  At 12 weeks post treatment

• The number of patients with acute Common Terminology for Adverse Events (CTCAE) bowel toxicity

  Clinician reported cumulative Grade 2 or worse CTCAE v5.0 acute GI toxicity from baseline up to 12 weeks post treatment (scale 0-5 with increasing severity to death at grade 5).

  At 12 weeks

Secondary Outcomes (12)

• The number of patients with late Radiation Oncology/ Toxicity Grading (RTOG) urinary toxicity

  At 24 months post completion of radiotherapy treatment

• The number of patients with late Common Terminology for Adverse Events (CTCAE) urinary toxicity

  At 24 months post completion of radiotherapy treatment

• The number of patients with late Radiation Oncology/ Toxicity Grading (RTOG) bowel toxicity

  At 24 months post completion of radiotherapy treatment

• The number of patients with late Common Terminology for Adverse Events (CTCAE) bowel toxicity

  At 24 months post completion of radiotherapy treatment

• Cumulative number of patients who experienced late Radiation Oncology/ Toxicity Grading (RTOG) urinary toxicity

  From 6-24 months

Other Outcomes (4)

• Urethral dose sparing and acute Radiation Oncology/ Toxicity Grading (RTOG)

  To be assessed at week 12 and month 24 post completion of treatment

• Urethral dose sparing and acute Common Terminology for Adverse Events (CTCAE)

  To be assessed at week 12 and month 24 post completion of treatment

• Urethral dose sparing late Radiation Oncology/ Toxicity Grading (RTOG)

  To be assessed at week 12 and month 24 post completion of treatment

Study Arms (1)

3 fractions of prostate Stereotactic Body Radiotherapy (SBRT)

EXPERIMENTAL

3 fractions of SBRT with image guidance using the RayPilot HypoCath system given on 3 consecutive days

Radiation: 3 fractions of prostate SBRT

Interventions

3 fractions of prostate SBRT RADIATION

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

3 fractions of prostate Stereotactic Body Radiotherapy (SBRT)

Eligibility Criteria

• Gender Eligibility Details: Must have prostate cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• T3a or above
• Gleason 4+3=7
• PSA\>20ng/ml

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Duncan B McLaren, MBBS

  NHS Lothian & University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Allan

CONTACT

+44 1315371463; richard.allan@nhslothian.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single arm Phase II study of 3 fractions of prostate SBRT

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: November 3, 2023
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)