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Salvage HDR for Locally Recurrent Prostate Cancer
RECRUITINGN/ASponsored by Aarhus University Hospital
Actively Recruiting
PhaseN/A
SponsorAarhus University Hospital
Started2021-04-01
Est. completion2025-03-01
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04231006
Summary
The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy
Eligibility
Age: 18 Years+Sex: MALEHealthy volunteers accepted
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
Conditions2
CancerProstate Cancer
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Actively Recruiting
PhaseN/A
SponsorAarhus University Hospital
Started2021-04-01
Est. completion2025-03-01
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04231006