NCT05715502

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The Greater Poland Cancer Centre · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prostate cancer is the second most common cancer among men in Poland. Currently, a large number of diagnosed patients undergo radical radiotherapy. Despite the high effectiveness of treatment, some patients experience failures in the form of regional and / or distant metastases, most often in the form of isolated local recurrence. In patients with suspected local recurrence, we can decide on emergency treatment after PET, pelvic MRI with an assessment of the prostate gland, and after excluding metastases. The oncological(NCCN ) and urological (EUA) recommendations allow salvage surgical treatment, observation, palliative pharmacological castration, or treatment using salvage brachytherapy. Salvage surgical treatment is associated with a 30-65% chance of cure in the top cancer centers in the world, and the risk of significant toxicity ranges from 17 to 48%. Treatment with brachytherapy, due to the intra-tissue nature and the short therapeutic range of radiation, can deliver a high dose to the treated area despite prior radiotherapy treatment and exhaustion of tolerance doses in critical organs, e.g., rectum and/or bladder. Treatment of the entire prostate gland gives a chance of disease-free survival for five years in approximately 65% of patients, according to the prospective study RTOG 0526. However, emergency treatment in this study was associated with a 14% risk of significant post-treatment toxicity requiring medical intervention. There are some reports in the literature on brachytherapy involving cancer in the part of the prostate gland (focal brachytherapy), but they are only retrospective. They show significant treatment efficacy and lower toxicity.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	brachytherapy	Radiation: focal low dose rate or high dose rate brachytherapy for the lesion with appropriate margin, defined in magnetic resonance or positron emission tomography All recruited participants will be treated with interstitial brachytherapy for local recurrence of prostate cancer. The low dose rate of brachytherapy is used with a total dose of 145 Gy in the clinical target volume for participants after hypofractionated radiotherapy, a high dose rate brachytherapy as monotherapy or boost with external beam radiotherapy The high dose rate brachytherapy with two fractions of 13 Gy in the clinical target volume with a 3 to 14 days break is used after primary low dose rate brachytherapy or external beam radiotherapy alone.

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-12-31
• Completion: 2028-12-31
• First posted: 2023-02-08
• Last updated: 2025-04-30

Locations

1 site across 1 country: Poland