Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective Focal Salvage Brachytherapy Study (FocaSaBra)

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

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.

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

• 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

Locations
Other Locations
Poland
Greater Poland Cancer Centre / Brachytherapy Department
RECRUITING
Poznan
Contact Information
Primary
Wojciech Burchardt, PhD, MD
wojciech.burchardt@wco.pl
+48505149659
Backup
Ewa Tańska, PhD, MSc.
ewa.tanska@wco.pl
+618850767
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Experimental
Experimental: All recruited participants will be treated with salvage partial (focal) prostate brachytherapy for the lesion of recurrent prostate cancer with appropriate margin.
Related Therapeutic Areas
Sponsors
Leads: The Greater Poland Cancer Centre

This content was sourced from clinicaltrials.gov