NCT04231006 Salvage HDR for Locally Recurrent Prostate Cancer
| NCT ID | NCT04231006 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aarhus University Hospital |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2025-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2021-04-01 with a primary completion date of 2025-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04231006 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04231006 currently recruiting?
Yes, NCT04231006 is actively recruiting participants. Contact the research team at simbuu@rm.dk for enrollment information.
Where is the NCT04231006 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT04231006 clinical trial?
NCT04231006 is sponsored by Aarhus University Hospital. The trial plans to enroll 50 participants.
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