Actively Recruiting
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
Led by NHS Lothian · Updated on 2026-01-12
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial focuses on men with localized early prostate cancer, specifically those with low or favorable intermediate risk according to NCCN criteria. Researchers are evaluating whether reducing the number of curative radiotherapy doses from 5 to 3 can maintain or lower side effects compared to the standard 5-dose treatment used in previous studies. The study uses a Phase II, single-arm design and employs the RayPilot HypoCath tumour tracking system to improve the accuracy of treatment delivery. The treatment involves delivering 3 fractions of prostate Stereotactic Body Radiotherapy (SBRT) on three consecutive days. The RayPilot HypoCath system, a device placed in the urinary catheter, continuously tracks prostate position during radiotherapy and pauses treatment if the prostate shifts, ensuring precise targeting. The study includes a planning phase with MRI and CT scans using rectal suppositories and bladder filling protocols to optimize imaging and treatment accuracy. Participants will undergo baseline assessments including blood tests and quality of life questionnaires before treatment. During the 3-day treatment period, the catheter with the tracking system is used, and treatment is carefully monitored. Follow-up visits occur frequently for two years post-treatment to track side effects using standard toxicity grading systems and patient-reported outcome measures. The study aims to assess both acute and late side effects and quality of life over this period.
CONDITIONS
Brief Title
The PRECISION Study: 3 Fractions of Prostate SBRT and RayPilot HypoCath Image Guidance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients with low and favorable intermediate NCCN prostate cancer risk
- Prostate volume under 80cc
- International Prostate Symptom Score (IPSS) under 20
- Maximum urinary flow rate (Q-max) above 10cc per second and urinary residual less than 150mls
- No history of transurethral resection of the prostate (TURP)
- No hip replacements
- No previous radiotherapy to the pelvis
- No active second malignancy except skin squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) within the last 2 years
- No history of inflammatory bowel disease
- Able to provide informed consent
You will not qualify if you...
- Tumor stage T3a or above
- Gleason score 4+3=7
- Prostate-specific antigen (PSA) level above 20 ng/ml
- Presence of co-morbid illness that would make treatment compliance difficult
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants undergo MRI and CT scans with preparation procedures including use of rectal suppository and urinary catheter to plan precise radiotherapy treatment.
2 visits (in-person) including MRI and CT scans
Duration - 3 consecutive days
Participants receive 3 fractions of prostate SBRT with RayPilot HypoCath image guidance on 3 consecutive days, including baseline assessments and catheter placement each day.
3 visits (in-person) on consecutive days for treatment delivery
Duration - 24 months
Participants attend multiple outpatient visits to assess PSA levels, toxicity, and quality of life using various patient-reported outcome measures for up to 24 months post treatment.
Visits at weeks 2, 4, 8, 12 and months 6, 9, 12, 18, 24 post treatment
Trial Site Locations
Total: 1 location
1
NHS Lothian
Edinburgh, United Kingdom
Actively Recruiting
Research Team
R
Richard Allan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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