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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Department of Oncology
RECRUITING
Aarhus
Contact Information
Primary
Simon Buus, MD
simbuu@rm.dk
+4540465291
Time Frame
Start Date: 2021-04-01
Estimated Completion Date: 2035-03-01
Participants
Target number of participants: 50
Treatments
Experimental: Single arm
Single arm
Related Therapeutic Areas
Sponsors
Leads: Aarhus University Hospital

This content was sourced from clinicaltrials.gov

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