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Two-fraction HDR Monotherapy for Localized Prostate Cancer

Primary Purpose

Prostate Adenocarcinoma, Localized Prostate Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Dose Rate Monotherapy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Brachytherapy, Radiotherapy, High Dose Rate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma. National Comprehensive Cancer Network low to intermediate risk stratification. No prior treatment for prostate cancer and no prior androgen deprivation therapy. Age >=18 years. Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%. Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist. Ability to understand and the willingness to sign a written informed consent document. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Exclusion Criteria: Any prior treatment for prostate cancer. Any prior androgen deprivation therapy. Is currently receiving any other investigational agents. Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure. Contraindications to general anesthesia. Contraindications to radiotherapy. Prior cryosurgery or cryotherapy to the prostate. Prior transurethral resection of the prostate within the previous 6 months.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HDR brachytherapy

Arm Description

Participants will receive the same radiotherapy technique, methods, and delivery will as standard of care 3 hours apart instead of receiving the radiotherapy on separate days.

Outcomes

Primary Outcome Measures

Proportion of participants with treatment-related adverse events
The proportion of participants with reported grade 3 or higher genitourinary (GU) or gastrointestinal (GI) toxicities, as graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported.

Secondary Outcome Measures

Mean Prostate Specific Antigen (PSA) Nadir
The mean (average) PSA nadir after treatment will be reported along with standard deviations.
Mean Time to PSA Nadir
The mean (average) time to PSA nadir after treatment will be reported along with standard deviations.
Mean Change in International Prostate Symptom Score (IPSS) over time
The mean change over time on scores for the International Prostate Symptom Score (IPSS) will be reported along with standard deviations. The IPSS measures the severity of lower urinary tract symptoms and erectile function with lower numbers indicating less change in symptoms. Seven questions with scores ranging from 1-5 are summed to create a total score. Scores of 1-7 indicate mild symptoms, scores of 8-19 indicate moderate symptoms, and scores of 20-35 indicate severe symptoms.

Full Information

First Posted
December 16, 2022
Last Updated
August 31, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05665738
Brief Title
Two-fraction HDR Monotherapy for Localized Prostate Cancer
Official Title
Two-fraction High Dose Rate Brachytherapy as Monotherapy Delivered Three Hours Apart in Localized Prostate Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a single center single arm prospective pilot study investigating the safety of high dose rate (HDR) brachytherapy as monotherapy delivered in 2 fractions 3 hours apart. HDR monotherapy has been established as safe and effective in this context, however previous studies have delivered 2 fractions on separate days, or at least 6 hours apart. Clinically, this regimen, if shown to be safe and effective in future studies, has the potential to reduce operative resources and logistical stresses on brachytherapy departments.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the safety of HDR monotherapy 13.5 Gy x 2 fractions delivered 3 hours apart in patients with low and intermediate risk prostate cancer. SECONDARY OBJECTIVES: I. To describe the prostate specific antigen (PSA) kinetics associated with HDR brachytherapy monotherapy 13.5 Gy x 2 fractions delivered 3 hours apart for low and intermediate risk prostate cancer. OUTLINE: Treatment will be administered on an outpatient basis. All treatment will be delivered over a single day. Participants will be followed for 6 months after last treatment or removal from study, or until death, whichever occurs first. Additional Follow up will be as per usual guidelines for prostate cancer, every 3 months following treatment with PSA for the first year, then every 4 months after year 2, and every 6 months after year 3 until 5 years of follow up are completed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma, Localized Prostate Carcinoma
Keywords
Brachytherapy, Radiotherapy, High Dose Rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HDR brachytherapy
Arm Type
Experimental
Arm Description
Participants will receive the same radiotherapy technique, methods, and delivery will as standard of care 3 hours apart instead of receiving the radiotherapy on separate days.
Intervention Type
Radiation
Intervention Name(s)
High Dose Rate Monotherapy
Other Intervention Name(s)
HDR Monotherapy, High dose rate brachytherapy
Intervention Description
High dose rate brachytherapy delivered in 13.5 Gy x 2 fractions over a single implant procedure 3 hours apart
Primary Outcome Measure Information:
Title
Proportion of participants with treatment-related adverse events
Description
The proportion of participants with reported grade 3 or higher genitourinary (GU) or gastrointestinal (GI) toxicities, as graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be reported.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Mean Prostate Specific Antigen (PSA) Nadir
Description
The mean (average) PSA nadir after treatment will be reported along with standard deviations.
Time Frame
Up to 6 months
Title
Mean Time to PSA Nadir
Description
The mean (average) time to PSA nadir after treatment will be reported along with standard deviations.
Time Frame
Up to 6 months
Title
Mean Change in International Prostate Symptom Score (IPSS) over time
Description
The mean change over time on scores for the International Prostate Symptom Score (IPSS) will be reported along with standard deviations. The IPSS measures the severity of lower urinary tract symptoms and erectile function with lower numbers indicating less change in symptoms. Seven questions with scores ranging from 1-5 are summed to create a total score. Scores of 1-7 indicate mild symptoms, scores of 8-19 indicate moderate symptoms, and scores of 20-35 indicate severe symptoms.
Time Frame
Up to 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma. National Comprehensive Cancer Network low to intermediate risk stratification. No prior treatment for prostate cancer and no prior androgen deprivation therapy. Age >=18 years. Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%. Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist. Ability to understand and the willingness to sign a written informed consent document. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Exclusion Criteria: Any prior treatment for prostate cancer. Any prior androgen deprivation therapy. Is currently receiving any other investigational agents. Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure. Contraindications to general anesthesia. Contraindications to radiotherapy. Prior cryosurgery or cryotherapy to the prostate. Prior transurethral resection of the prostate within the previous 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nauman Malik, MD
Phone
415-476-5721
Email
Nauman.Malik@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Chow Hsu, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nauman Malik, MD
Phone
415-476-5721
Email
Nauman.Malik@ucsf.edu
Phone
877-827-3222
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
I-Chow Hsu, MD
First Name & Middle Initial & Last Name & Degree
Nauman Malik, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31522882
Citation
Martell K, Mendez LC, Chung HT, Tseng CL, Alayed Y, Cheung P, Liu S, Vesprini D, Chu W, Wronski M, Szumacher E, Ravi A, Loblaw A, Morton G. Results of 15 Gy HDR-BT boost plus EBRT in intermediate-risk prostate cancer: Analysis of over 500 patients. Radiother Oncol. 2019 Dec;141:149-155. doi: 10.1016/j.radonc.2019.08.017. Epub 2019 Sep 12.
Results Reference
background
PubMed Identifier
33461894
Citation
Viani GA, Arruda CV, Assis Pellizzon AC, De Fendi LI. HDR brachytherapy as monotherapy for prostate cancer: A systematic review with meta-analysis. Brachytherapy. 2021 Mar-Apr;20(2):307-314. doi: 10.1016/j.brachy.2020.10.009. Epub 2021 Jan 15.
Results Reference
background
PubMed Identifier
32146259
Citation
Morton G, McGuffin M, Chung HT, Tseng CL, Helou J, Ravi A, Cheung P, Szumacher E, Liu S, Chu W, Zhang L, Mamedov A, Loblaw A. Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy. Radiother Oncol. 2020 May;146:90-96. doi: 10.1016/j.radonc.2020.02.009. Epub 2020 Mar 5.
Results Reference
background
PubMed Identifier
32918971
Citation
Alayed Y, Loblaw A, McGuffin M, Chung HT, Tseng CL, D'Alimonte L, Cheung P, Liu S, Chu W, Szumacher E, Helou J, Ravi A, Haider M, Mamedov A, Zhang L, Morton G. Single-fraction HDR brachytherapy as monotherapy in low and intermediate risk prostate cancer: Outcomes from two clinical trials with and without an MRI-guided boost. Radiother Oncol. 2021 Jan;154:29-35. doi: 10.1016/j.radonc.2020.09.007. Epub 2020 Sep 10.
Results Reference
background
PubMed Identifier
34961659
Citation
Corkum MT, Achard V, Morton G, Zilli T. Ultrahypofractionated Radiotherapy for Localised Prostate Cancer: How Far Can We Go? Clin Oncol (R Coll Radiol). 2022 May;34(5):340-349. doi: 10.1016/j.clon.2021.12.006. Epub 2021 Dec 25.
Results Reference
background
PubMed Identifier
25736733
Citation
Kukielka AM, Dabrowski T, Walasek T, Olchawa A, Kudzia R, Dybek D. High-dose-rate brachytherapy as a monotherapy for prostate cancer--Single-institution results of the extreme fractionation regimen. Brachytherapy. 2015 May-Jun;14(3):359-65. doi: 10.1016/j.brachy.2015.01.004. Epub 2015 Feb 28.
Results Reference
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Two-fraction HDR Monotherapy for Localized Prostate Cancer

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