Back to resultsA Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence
Primary Purpose
Prostate Cancer, HDR
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
High-Dose-Rate Brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Brachytherapy, Prostate Cancer, High-Dose-Rate (HDR)
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
Sites / Locations
- University of RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: High-Dose-Rate prostate brachytherapy
Arm Description
High-Dose-Rate brachytherapy, 2 fractions
Outcomes
Primary Outcome Measures
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
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Measured by adverse event severity and quantity
Secondary Outcome Measures
Progression Free Survival
Measure of time from study enrollment until progression.
Full Information
NCT ID
NCT04645810
First Posted
November 22, 2020
Last Updated
July 17, 2023
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT04645810
Brief Title
A Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence
Official Title
A Pilot Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, HDR
Keywords
Brachytherapy, Prostate Cancer, High-Dose-Rate (HDR)
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: High-Dose-Rate prostate brachytherapy
Arm Type
Experimental
Arm Description
High-Dose-Rate brachytherapy, 2 fractions
Intervention Type
Radiation
Intervention Name(s)
High-Dose-Rate Brachytherapy
Intervention Description
High-Dose-Rate Brachytherapy Targeting only to AXUMIN PET Visible Lesion
Primary Outcome Measure Information:
Title
Number of patients with prostate-specific antigen (PSA) levels rising of 2ng/ml or above
Description
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
Time Frame
6 Months
Title
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Description
Measured by adverse event severity and quantity
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
Measure of time from study enrollment until progression.
Time Frame
6 Months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Huggins
Phone
585-275-5973
Email
Christine_Huggins@URMC.Rochester.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Zhang
Organizational Affiliation
University of Rochester Wilmot Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Huggins
Phone
585-275-5973
Email
Christine_Huggins@URMC.Rochester.edu
First Name & Middle Initial & Last Name & Degree
Hong Zhang, MD
12. IPD Sharing Statement
Learn more about this trial
A Study of Focal Salvage High-Dose-Rate Brachytherapy for Prostate Gland Only Recurrence
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