๐ฌIn plain words
What the trial is, and whether it could suit you
The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Man โฅ 18 years, who had definitive EBRT or BT for prostate cancer T1-3b, N0-1, M0
* โฅ 2 years since the end of primary radiotherapy
* PSA recurrence Phoenix criteria (nadir + 2)
* No evidence of regional lymph nodes or distant metastases on PSMA PET/CT
* MRI guided biopsy-proven local recurrence of adenocarcinoma in the prostate gland or seminal vesicles
* GTV identifiable on mpMRI
* No current endocrine therapy
* Plasma testosterone โฅ1.75 nm/l
* PSA doubling time โฅ 6 months and โค 24 months
* Performance status 0-1
* DAN PSS score โค 20
* Maximal urinary flow โฅ 10 ml/s
* Life expectancy \> 5 years
* PSA โค 10 ug/L at recurrence
Exclusion Criteria:
* Pubic arc interference or major calcifications within the prostate gland.
* Contraindication for spinal or general anaesthesia.
* Conditions indicating that the patient cannot go through the radiation therapy or follow-up, or a condition where the treating oncologist thinks the patient should not participate in the trial, for example due to language problems.
* Inflammatory bowel disease
* Contraindications to 3T MRI
* eGFR \< 30 ml/min
* โฅ Gr 3 urinary toxicity at baseline as assessed by CTCAE 4
๐
What it tests
- High dose rate brachytherapy
Department of Oncology
Aarhus, Denmark
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.