Clinical Trials in Denmark / NCT04231006
Recruiting
Not applicable
Salvage HDR for Locally Recurrent Prostate Cancer
NCT04231006 · tracked via the Priya Life Science Denmark tracker
Condition(s) studied
Prostate Cancer
Investigational drug(s) / intervention(s)
High dose rate brachytherapy
High dose rate brachytherapy: High dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT
Study summary
The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy
Eligibility
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
Primary outcome measure(s)
- Time to castration-resistant prostate cancer — 10 years
The time from intervention until the prostate cancer becomes castration resistant
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Oncology | Aarhus | Region Midt | Recruiting |
More Aarhus University Hospital trials in Denmark
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Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
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Risk Factors, Incidence, and Progression of Lymphedema Among Men With Prostate Cancer. The AWARE Cohort
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The ProCaRis Study: Prostate Cancer Risk Assessment in General Practice
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04231006 on ClinicalTrials.gov ↗ ← All trials in Denmark