NCT03312972

Focal Salvage HDR Brachytherapy for Locally Recurrent Prostate Cancer in Patients Treated With Prior Radiotherapy

F-SHARP: A Phase I/II Trial of Focal Salvage High-dose-rate BRachytherapy for Locally Recurrent Prostate Cancer in Patients Treated With Prior Radiotherapy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Loyola University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This purpose of this study is to evaluate the safety and effectiveness of a technique called focal high-dose-rate (HDR) brachytherapy as treatment for prostate cancer that has come back in the prostate after prior radiotherapy. The study will examine the safety and efficacy of the treatment. The type of radiation that participants in this research will receive is targeted directly at the areas of the prostate where recurrent disease is evident, while avoiding treatment of the normal appearing prostate. This involves the placement of a radioactive material in the affected area of the prostate temporarily, where it remains for a short period of time, and then is subsequently removed using a minimally invasive technique called HDR Brachytherapy.

Detailed description

The goal of any radiation treatment plan is to achieve maximal disease response with minimal toxicity. HDR brachytherapy offers a promising definitive treatment option in the setting of Locally Recurrent Prostate Cancer after prior definitive radiation, based on the limited data described above, with achievement of biochemical disease control in a large percentage of patients with relatively low toxicity. With focal HDR brachytherapy, the investigators can treat the isolated areas of disease, while avoiding normal prostate tissue, with the goal of further improving toxicity rates. The investigators hypothesize that using single fraction, focal HDR brachytherapy performed with one single implant for the treatment of LRPC is feasible and without excess toxicity, and can be safely delivered. This should allow for better patient convenience and cost and improved treatment dosimetry and planning, as it will decrease the risk of catheter displacement between fractions, which will hopefully correlate to less GU and non-GU acute toxicity. The primary objective is to determine the acute and late GU and GI toxicity of single fraction focal HDR salvage brachytherapy (primary endpoint).

Conditions

• Locally Recurrent Prostate Cancer

Interventions

Type	Name	Description
RADIATION	HDR Brachytherapy	HDR Brachytherapy implant, deliver 1 to 2 fractions, Up to 30 Gray (Gy) to target lesion

Timeline

• Start date: 2017-08-28
• Primary completion: 2026-03-31
• Completion: 2026-07-31
• First posted: 2017-10-18
• Last updated: 2025-09-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study