Prospective Evaluation of Hypofractionation Proton Beam Therapy With Concurrent Treatment of the Prostate and Pelvic Nodes for Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Prospective Evaluation of Hypofractionation Proton Beam Therapy With Concurrent Treatment of the Prostate and Pelvic Nodes for Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02874014
• Other study ID #: 15-009528
• Secondary ID: MC1651
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 25, 2016
• Est. completion date: October 31, 2024

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is to examine a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180 centigray/fraction) simultaneously. The overall treatment time is 5 weeks.

Description:

Proton beam therapy can provide a therapeutic gain by offering at least equivalent (or superior) tumor control while reducing the risk of radiation toxicity, in comparison with conventional photon-based external beam radiotherapy, given its dose-deposition characteristics. Currently the clinical target volume of proton beam for the treatment of prostate cancer has been mostly limited to the prostate and the seminal vesicles. There has been no study of proton beam therapy to treat both the primary tumor in the prostate and the regional pelvic nodes simultaneously using a moderate hypofractionation regimen. The study is a prospective, single-arm, clinical trial to evaluate a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The clinical target volumes of proton beam therapy include both the prostate/seminal vesicles and the regional pelvic nodes. The primary objective is to assess late grade ≥ 3 gastrointestinal (GI) and genitourinary (GU) toxicity. The secondary objectives are to evaluate late grade ≥ 2 GI and GU toxicity, acute grade ≥ 3 GI and GU toxicity, and disease-free survival including freedom from PSA (prostate specific antigen) relapse at 5 years. The study provides an avenue to examine the safety, efficacy, cost effectiveness, and convenience of a moderate hypofractionation regimen (5-week course) of proton beam therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: October 31, 2024
• Est. primary completion date: February 8, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male; Age = 18 years.
• Histological confirmation of adenocarcinoma of the prostate within 6 months of study enrollment.
• Clinical stage T1-2 N0 M0, Gleason Score 7, Prostate Specific Antigen (PSA) 20-100 ng/mL, or Clinical stage Any T N0 M0, Gleason Score 8-10, PSA = 100 ng/mL, or Clinical stage T3-4 N0 M0, any Gleason Score, PSA = 100 ng/mL, or Clinical stage T1-2 N0 M0, Gleason Score 4+3, PSA 10-20 ng/mL
• Zubrod performance score (PS) = 1
• Total bilirubin, aspartate aminotransferase, alkaline phosphatase, and serum creatinine: < 2 x upper normal limit
• Signed informed consent.

Exclusion Criteria:

• Any known nodal (N1) or distant metastasis (M1)
• Previous androgen deprivation therapy lasting more than 6 months
• History of inflammatory bowel disease
• Presence of a hip prosthesis
• Prior pelvic radiotherapy or prostatectomy
• Prior or concurrent antineoplastic agents (chemotherapy)
• Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years of diagnosis of prostate cancer.
• Inability to start the protocol treatment within 1 month after study enrollment.
• Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late Grade = 3 Gastrointestinal (GI) and Genitourinary (GU) Toxicity of Interest, Using the CTCAE v4.0	Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. A late GI or GU toxicity will be defined as a GI or GU toxicity that occurs between 3 months and 2 years from the completion of proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation.	Between 3 months and 24 months post proton beam therapy
Secondary	Late Grade = 2 GI and GU Toxicity of Interest, Using the CTCAE v4.0	Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. A late GI or GU toxicity will be defined as a GI or GU toxicity that occurs between 3 months and 2 years from the completion of proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation	Between 3 months and 24 months post proton beam therapy
Secondary	Acute Grade = 3 GI and GU Toxicity of Interest Within 3 Months Post Proton Beam Therapy, Using the CTCAE v4.0	Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation	Within 3 months post proton beam therapy
Secondary	Disease-free Survival Including Freedom From PSA Relapse at 5 Years Post Proton Beam Therapy	Disease-free survival is defined as the time from registration until the time of the first occurrence of biochemical failure, local recurrence, regional recurrence, distant metastases, or death due to any cause. The distribution of disease-free survival will be estimated using the method of Kaplan-Meier.	5 years post proton beam therapy
Secondary	Disease-specific Survival at 5 Years Post Proton Beam Therapy	Disease-free survival is defined as the time from registration until the time of the first occurrence of biochemical failure, local recurrence, regional recurrence, distant metastases, or death due to any cause. The distribution of disease-free survival will be estimated using the method of Kaplan-Meier.	5 years post proton beam therapy

External Links

•   Mayo Clinic Clinical Trials