Focal salvage brachytherapy for recurrent prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness and safety of focal salvage high dose rate brachytherapy (HDR BT) for patients with locally recurrent prostate cancer following definitive external beam radiotherapy. It aims to determine the feasibility of using multiparametric pelvic MRI and PSMA PET/CT to guide the treatment. The study will assess both the efficacy of the treatment and any associated toxicities in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Man ≥ 18 years, who had definitive EBRT or BT for prostate cancer T1-3b, N0-1, M0
* ≥ 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 ≥1.75 nm/l
* PSA doubling time ≥ 6 months and ≤ 24 months
* Performance status 0-1
* DAN PSS score ≤ 20
* Maximal urinary flow ≥ 10 ml/s
* Life expectancy \> 5 years
* PSA ≤ 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
* ≥ Gr 3 urinary toxicity at baseline as assessed by CTCAE 4

Where it's running

• Department of Oncology
  Aarhus, Region Midt, Denmark Recruiting

Study contacts

• Study coordinator: Simon Buus, MD
• Email: simbuu@rm.dk
• Phone: +4540465291

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.