Loading search results
PRECISION
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 study identifier
interventional
100
1 country
1
Study Start
November 1, 2024
Actual (reported)Primary Completion
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2023
Actual (reported)November 3, 2023
Actual (reported)November 1, 2024
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
3 fractions of SBRT with image guidance using the RayPilot HypoCath system given on 3 consecutive days
Radical radiotherapy using only 3 fractions of prostate SBRT over 3 consecutive days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
NHS Lothian
Edinburgh, United Kingdom
Duncan B McLaren, MBBS
NHS Lothian & University of Edinburgh
First Submitted
October 10, 2023
First Posted
November 3, 2023
Study Start
November 1, 2024
Actual (reported)Primary Completion
November 1, 2026
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
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
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
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 12, 2026
Record last verified: 2026-01
The data generated is specific to using the RayPilot HypoCath System when delivering the treatment. Results will be presented and published but individual patient data would not be supplied
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: