Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Herlev Hospital
Age
18–80
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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).
