Status:
ENROLLING_BY_INVITATION
Cancer of the Prostate Treated With Focal Implantation of a RadioactivE Source
Lead Sponsor:
Herlev Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
NA
Brief Summary
The purpose is to assess and describe the oncological and functional outcomes following the introduction of curative targeted focal brachytherapy of prostate cancer in Denmark. Men with a single MRI-...
Eligibility Criteria
Inclusion
- Age 40-80; Performance status 0-1; \>10 yr. life expectancy
- Candidate for curative intended treatment
- PSA \<20 ng/mL
- Clinical stage T1c or T2a
- Prostate anatomy suitable for focal brachytherapy
- MRI identified index tumour (PI-RADS 3-5) with PCa confirmed on biopsy
- A single index tumour focus with Gleason score 6 (\>10 mm maximum cancer-core length \[MCCL\]), Gleason score 3+4 (any MCCL) or Gleason core 4+3 (\<10 mm MCCL)
- Systematic biopsies (≥10-12 cores) with no or low volume Gleason score 6 (3+3) PCa only
- No severe urinary obstructive symptoms (e.g., urinary retention needing indwelling catheter)
- Fit to undergo all procedures in the protocol
- Included subjects should be able to participate in the planned follow-up (either on-site visits or telephone consultation accepted at specific time-points).
- Included subjects should be able to read and understand the study details, and provide written informed consent to participate
Exclusion
- If any of the following criteria is present, the subject cannot participate in the study:
- Not a candidate for curative intended treatment (e.g., other active malignancy except for non-melanoma skin-cancer, life-expectancy \<10 years, severe comorbidities etc.)
- Prior surgical or radiation treatment of PCa; Prior transurethral-resection (TUR-P) is not an exclusion criterion.
- Evidence/suspicion of extra prostatic extension on MRI
- Tumour focus \>50% of one prostate half on MRI corresponding to stage \>T2a
- Briganti 2018 score ≥7%
- PCa with intraductal carcinoma, cribriform pattern, or small cell component
- Any anatomical or clinical conditional not suitable for brachytherapy (e.g., imperforate anus, prostatitis, inflammatory bowel disease, severe calcifications etc.)
- Any contraindication for prostate MRI (e.g., claustrophobia, pacemaker, estimated glomerular filtration rate ≤30 mL/min/1.73m2)
- Reduction in MRI image quality that interferes with diagnosis caused by e.g., hip replacement surgery or other metal implants in the pelvic area.
- Any medical condition precluding procedures
- Any medication that may alter prostate morphology or alter MRI appearance (e.g., 5-alpha reductase inhibitors, prior androgen deprivation therapy \[ADT\])
- Subjects who are unwilling or unable to adhere to the study requirements (including treatment, required assessments and follow-up).
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2037
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06080113
Start Date
November 1 2023
End Date
June 1 2037
Last Update
March 12 2025
Active Locations (1)
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1
Department of Urology, Herlev University Hospital Herlev
Herlev, Denmark, 2730