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Taking people in DenmarkNo phase

Tests high dose radiation for prostate cancer that has returned locally

Tests focal radiation placed inside the body in men whose prostate cancer returned locally.

Plain-language title generated from the registry record
Registry title: Salvage HDR for Locally Recurrent Prostate Cancer

Key facts

Where
Aarhus, DenmarkSee the site

Where in Denmark

  • Department of OncologyAarhus, DenmarkTaking people

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Trial details

Who runs it
Aarhus University Hospital
Trial code
NCT04231006
Record updated
21 July 2021
Original description
The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapyRead full original descriptionShow less

Salvage High Dose Rate Brachytherapy for Local Recurrence in Prostate Cancer: A Phase II Trial

The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy

Inclusion: 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: 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; eGFR < 30 ml/min; Pubic arc interference or major calcifications within the prostate gland; Contraindication for spinal or general anaesthesia; Contraindications to 3T MRI; ≥ Gr 3 urinary toxicity at baseline as assessed by CTCAE 4.

ClinicalTrials.gov NCT04231006