Focal Salvage Brachytherapy Study (FocaSaBra)

Launched by THE GREATER POLAND CANCER CENTRE · Jan 27, 2023

Keywords

ClinConnect Summary

The Focal Salvage Brachytherapy Study (FocaSaBra) is a clinical trial aimed at understanding the safety of a treatment called focal brachytherapy for men with prostate cancer who have had previous radiation therapy. This study is looking at patients who have experienced a local recurrence of their cancer, meaning the cancer has returned in the same area after treatment. By focusing on this specific approach, researchers hope to learn more about how well it works and what side effects it might have.

To participate in this trial, men aged 65 to 74 who have been diagnosed with recurrent prostate cancer after earlier treatment may be eligible. Key requirements include having a specific type of cancer confirmed by a biopsy, showing no signs of cancer spread to other parts of the body, and having a prostate-specific antigen (PSA) level below 10 ng/ml. Participants can expect to undergo a procedure that involves placing small radioactive seeds in the prostate to target the cancer directly. If you or a loved one are considering this trial, it's important to discuss it with your healthcare provider to see if it’s the right option.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Histopathologically confirmed by biopsy (fusion mapping biopsy preferred) recurrence of prostate cancer after prior radical radiotherapy (brachytherapy, external beam radiotherapy alone or with brachytherapy boost, stereotaxic radiotherapy)
• • Localized tumor lesion assessed by MRI or in the case of MR contraindications with TRUS and CT
• • Exclusion of distant metastases using CT, MR, or PET imaging
• • PSA doubling time over six months
• • PSA value \<10 ng / ml
• • No anti-androgen treatment in the year prior
• • Dysuria on the IPSS (International Prostate Symptom Score) ≤ 20 points
• • General condition according to the WHO scale ≤ 2
• • Signing informed consent to participate in the study
• Exclusion Criteria:
• • PSA value\> 10ng / ml
• • General condition according to the WHO scale\> 2
• • Dysuria on the IPSS scale\> 20 points
• • PSA doubling time \<6 months
• • Inability to discontinue anticoagulants.
• • An active urinary tract infection.
• • Contraindications to general anesthesia
• • Active inflammatory bowel diseases.
• • Second active cancer or treatment with completion less than 3 years earlier, except for low-stage skin cancer
• • Estimated Survival \<5 years