Focal Salvage Brachytherapy Study (FocaSaBra)
Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective Focal Salvage Brachytherapy Study (FocaSaBra)
About This Trial
- This study is testing the safety and side effects of a targeted internal radiation treatment that focuses only on the specific area where cancer has returned inside the prostate.
- It is open to men whose prostate cancer has come back locally after previous radiation therapy, has not spread to other parts of the body, and is growing relatively slowly.
- To take part, your PSA levels must be below a certain limit, and you should not have received hormone therapy in the past year.
- Before considering this trial, you should know that the procedure requires anesthesia, temporarily pausing any blood-thinning medications, and having generally manageable urinary symptoms with no active bowel or urinary infections.
More Information
- The aim of this prospective phase II study is to evaluate the toxicity of salvage partial (focal) prostate brachytherapy in patients after prior radiotherapy (standard teleradiotherapy with / without brachytherapy, hypofractionated, self-reactive HDR / LDR brachytherapy) with local recurrence on the part of the prostate gland.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing the safety and side effects of a targeted internal radiation treatment that focuses only on the specific area where cancer has returned inside the prostate.
Study Details
- Start Date: May 1, 2022
- Lead Sponsor: The Greater Poland Cancer Centre
Full 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 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
Treatments
- Radiation: brachytherapy