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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645810
• Other study ID #: RGUP20045
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 29, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: July 2023
• Source: University of Rochester
• Contact: Christine Huggins
• Phone: 585-275-5973
• Email: Christine_Huggins[@]URMC.Rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HDR
• Prostate Cancer
• Prostatic Neoplasms
• Recurrence

Intervention

Radiation:
• High-Dose-Rate Brachytherapy
High-Dose-Rate Brachytherapy Targeting only to AXUMIN PET Visible Lesion

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with prostate-specific antigen (PSA) levels rising of 2ng/ml or above	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	6 Months
Primary	Incidence of Treatment-Related Adverse Events [Safety and Tolerability]	Measured by adverse event severity and quantity	6 Months
Secondary	Progression Free Survival	Measure of time from study enrollment until progression.	6 Months