A Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence
Conditions
Prostate Cancer, HDRSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Therese Smudzin
- 585-275-7848
- [email protected]
Principal Investigator
- Hong Zhang
Eligibility Criteria
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 Plan
Experimental: High-Dose-Rate prostate brachytherapy
EXPERIMENTAL
High-Dose-Rate brachytherapy, 2 fractions
PROCEDURE:
High-Dose-Rate BrachytherapyDescription:
High-Dose-Rate Brachytherapy Targeting only to AXUMIN PET Visible Lesion
Outcome Measures
Primary Outcome Measures
Number of patients with prostate-specific antigen (PSA) levels rising of 2ng/ml or above
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Secondary Outcome Measures
Progression Free Survival
Timeline
Last Updated
August 6, 2024Start Date
November 27, 2020Today
February 5, 2025Completion Date ( Estimated )
May 31, 2027
Sponsors of this trial
Lead Sponsor
University of Rochester