Two-fraction HDR Monotherapy for Localized Prostate Cancer

Prostate Adenocarcinoma Clinical Trial

Official title:

Two-fraction High Dose Rate Brachytherapy as Monotherapy Delivered Three Hours Apart in Localized Prostate Cancer: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05665738
• Other study ID #: 23721
• Secondary ID: NCI-2024-01993
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 30, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: Jamese Johnson
• Phone: 415-530-9805
• Email: Jamese.Johnson[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 17
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.

2. National Comprehensive Cancer Network low to intermediate risk stratification.

3. No prior treatment for prostate cancer and no prior androgen deprivation therapy.

4. Age >=18 years.

5. Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%.

6. Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist.

7. Ability to understand and the willingness to sign a written informed consent document.

8. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

9. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

10. 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.

11. 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:

1. Any prior treatment for prostate cancer.

2. Any prior androgen deprivation therapy.

3. Is currently receiving any other investigational agents.

4. Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure.

5. Contraindications to general anesthesia.

6. Contraindications to radiotherapy.

7. Prior cryosurgery or cryotherapy to the prostate.

8. Prior transurethral resection of the prostate within the previous 6 months.

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms

Intervention

Radiation:
• High Dose Rate Monotherapy
High dose rate brachytherapy delivered in 13.5 Gy x 2 fractions over a single implant procedure 3 hours apart

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 6 months
Secondary	Mean Prostate Specific Antigen (PSA) Nadir	The mean (average) PSA nadir after treatment will be reported along with standard deviations.	Up to 6 months
Secondary	Mean Time to PSA Nadir	The mean (average) time to PSA nadir after treatment will be reported along with standard deviations.	Up to 6 months
Secondary	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.	Up to 6 months