RecruitingNot ApplicableNCT04231006

Salvage HDR for Locally Recurrent Prostate Cancer

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

Sponsor

Aarhus University Hospital

Enrollment

50 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

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

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

RADIATIONHigh 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

Department of Oncology

Aarhus, Region Midt, Denmark

View Full Details on ClinicalTrials.gov

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NCT04231006