A Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence

Not Applicable

Recruiting

• Conditions: Prostate Cancer; HDR
• Interventions: Procedure: High-Dose-Rate Brachytherapy

• Registration Number: NCT04645810
• Lead Sponsor: University of Rochester

Brief Summary

The purpose of this study is to learn more about what effects the use of high-dose-rate (HDR) brachytherapy on prostate cancer recurrence, seen by AXUMIN PET scan, has on prostate cancer.

Detailed Description

In this study the investigator would like to better understand the use of high-dose rate (HDR) brachytherapy to target only recurrent prostate cancer that can be seen by AXUMIN PET scan. The use of HDR brachytherapy for prostate cancer is not new, but it is a more recent advancement to use it to treat only what can be seen instead of the whole prostate.

Study Timeline

• Study First Submitted: 2020-11-22
• Study First Submitted QC: 2020-11-22
• Study First Posted: 2020-11-27
• Study Start: 2021-10-29
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-03
• Last Update Posted: 2024-08-06
• Primary Completion: 2026-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

History of histologically confirmed, clinically localized adenocarcinoma of the prostate treated with external beam radiation, brachytherapy, or combination of external beam radiation and brachytherapy, with curative intent completed at least 24 months ago F-18 fluciclovine (AXUMIN) PET scan within 90 days prior to registration demonstrating recurrent lesion within the prostate gland Biopsy confirmation of disease recurrence within the prostate gland Age ≥ 18 KPS ≥ 70% Suitable candidate for brachytherapy based on established criteria IPSS score <16 No pelvic arch interference No Rectal fistula/fissure Fit for general or spinal anesthesia No history of urethral stricture Ability to understand, and willingness to sign the written informed consent

Exclusion Criteria

Evidence of metastatic or nodal disease outside of the prostate gland on AXUMIN PET scan within 90 days prior to enrollment Patient unable to have MRI Patients with neuroendocrine or small cell carcinoma of the prostate TURP within 6 months prior to enrollment History of Crohn's disease, ulcerative colitis, or known radiation proctitis Inability to understand spoken and written English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: High-Dose-Rate prostate brachytherapy	High-Dose-Rate Brachytherapy	High-Dose-Rate brachytherapy, 2 fractions

Primary Outcome Measures

Name	Time	Method
Number of patients with prostate-specific antigen (PSA) levels rising of 2ng/ml or above	6 Months	Rate of prostate-specific antigen (PSA) failure after focal salvage HDR in the setting of prostate only recurrence after primary non-surgical treatment, defined as a PSA rise of 2 ng/ml or more above the nadir at 6 months
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]	6 Months	Measured by adverse event severity and quantity

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	6 Months	Measure of time from study enrollment until progression.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States