Salvage HDR for Locally Recurrent Prostate Cancer

Launched by AARHUS UNIVERSITY HOSPITAL · Jan 13, 2020

Keywords

ClinConnect Summary

**Summary of the Clinical Trial: Salvage HDR for Locally Recurrent Prostate Cancer**

This clinical trial is studying a treatment called focal salvage brachytherapy for men with prostate cancer that has come back in the same area after they’ve already received radiation therapy. The goal is to see if this targeted radiation can help treat the recurrence effectively. The study is currently looking for participants aged 18 and older who meet specific criteria, such as having had prior radiation treatment for prostate cancer at least two years ago and showing signs of a return of cancer without it spreading to other areas of the body.

To be eligible for the trial, participants should have a confirmed diagnosis of prostate cancer recurrence through a specific type of imaging and biopsy. They should also have a certain level of prostate-specific antigen (PSA), which is a marker for prostate cancer, and not have any significant urinary or health problems that could complicate treatment. Participants can expect to receive precise radiation therapy aimed at the cancer site, and they will be monitored closely throughout the trial to assess how well the treatment is working. If you or a loved one might qualify, this could be an important opportunity to explore a new treatment approach for recurrent prostate cancer.

Gender

MALE

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