Cancer of the Prostate Treated With Focal Implantation of a RadioactivE Source

Launched by HERLEV HOSPITAL · Oct 6, 2023

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• 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).