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Recruiting Not applicable

Salvage HDR for Locally Recurrent Prostate Cancer

NCT04231006 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2021-04-01
Last updated
2021-07-21

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

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
Department of Oncology Aarhus Region Midt Recruiting
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