Proton Radiation Therapy for the Treatment of Patients with High Risk Prostate Cancer

NCT ID: NCT04725903

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2026-12-31

Brief Summary

This phase II trial investigates whether proton radiation therapy directed to the prostate tumor, pelvic, and para-aortic lymph nodes, is an effective way to treat patients with high-risk or lymph node positive prostate cancer who are receiving radiation therapy, and if it will result in fewer gastrointestinal and genitourinary side effects. Proton beam therapy is a new type of radiotherapy that directs multiple beams of protons (positively charged subatomic particles) at the tumor target, where they deposit the bulk of their energy with essentially no residual radiation beyond the tumor. By reducing the exposure of the healthy tissues and organs to radiation in the treatment of prostate cancer, proton therapy has the potential to better spare healthy tissue and reduce the side effects of radiation therapy.

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the rate of acute grade 2+ gastrointestinal toxicity compared to historical photon treatments.

SECONDARY OBJECTIVES:

I. To determine the rate of acute grade 2+ genitourinary toxicity compared to historical photon treatments.

II. To assess the feasibility of extended-field proton irradiation of high-risk prostate.

III. To demonstrate safety of proton therapy followed by high dose rate (HDR) boost.

IV. To determine patient-reported outcomes (PROs) of toxicity.

OUTLINE:

Patients undergo conventionally fractionated proton beam therapy daily on Monday-Friday. Patients may receive a high-dose rate brachytherapy boost.

After completion of study treatment, patients are followed up at 1, 3, 6, 9 and 12 months, and 1.5, 2, 2.5, and 3 years.

Conditions

Stage III Prostate Cancer AJCC V8; Stage IIIA Prostate Cancer AJCC V8; Stage IIIB Prostate Cancer AJCC V8; Stage IIIC Prostate Cancer AJCC V8

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (proton beam therapy)

Patients undergo conventionally fractionated or hypofractionated proton beam therapy daily on Monday-Friday directed to the prostate, pelvic lymph nodes, and para-aortic lymph nodes. Patients may receive an optional high-dose rate brachytherapy boost. Androgen deprivation therapy is required but left to the discretion of the treating physician.

Group Type: EXPERIMENTAL

High-Dose Rate Brachytherapy

Intervention Type: RADIATION

Receive high-dose rate brachytherapy boost

Proton Beam Radiation Therapy

Intervention Type: RADIATION

Undergo proton beam therapy

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Survey Administration

Intervention Type: OTHER

Ancillary studies

Interventions

High-Dose Rate Brachytherapy

Receive high-dose rate brachytherapy boost

Intervention Type: RADIATION

Proton Beam Radiation Therapy

Undergo proton beam therapy

Intervention Type: RADIATION

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Survey Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Brachytherapy, High Dose; PBRT; Proton; Proton Radiation Therapy; Radiation, Proton Beam; Quality of Life Assessment

Eligibility Criteria

Inclusion Criteria

• Pathologically confirmed high-risk prostate cancer fulfilling any one of the following criteria:

• Gleason grade 8 or higher
• cT3b (seminal vesicle involvement) or cT4
• Prostate specific antigen [PSA] > 20 (or PSA >10 if on finasteride)
• Clinically or pathologically positive regional lymph nodes within the inguinal, external iliac, internal iliac, obturator, peri-rectal, pre-sacral, common iliac, or lower para-oaortc (inferior to the L2-L3 interspace) basins
• Zubrod performance status 0-2
• Complete blood cell (CBC)/differential obtained within 90 days prior to registration on study
• Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
• Platelets >= 100,000 cells/mm^3
• Hemoglobin >= 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
• Patient must be able to provide study specific informed consent

Exclusion Criteria

• Absence of bone metastasis by bone scan or metabolic imaging (e.g. NaF PET, FACBC PET, PSMA PET, etc.) before the start of therapy.
• Absence of distant lymph node metastasis by CT and/or MRI before the start of therapy.
• Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
• Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
• Uncontrolled intercurrent illness including, but not limited to, inflammatory bowel disease, human immunodeficiency virus infection, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Pretesh Patel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pretesh R Patel

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pretesh Patel, MD

Role: CONTACT

pretesh.patel@emory.edu

404-778-3473

Facility Contacts

Ardith R. DeShay

Role: primary

adeshay@emory.edu

404-686-1858

Pretesh R. Patel, MD

Role: backup

Other Identifiers

NCI-2020-07113

Identifier Type: REGISTRY

Identifier Source: secondary_id

RAD5131-20

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000329

Identifier Type: -

Identifier Source: org_study_id