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

NCT04725903 | Recruiting DMC FDA Device

• 4 other identifiers: STUDY00000329NCI-2020-07113RAD5131-20P30CA138292
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Acute grade 2+ gastrointestinal (GI) toxicity

  The rate of grade 2+ gastrointestinal toxicity within 30 days of receiving radiation therapy (RT) will be measured. It will be compared to the theorized reduction to 24% toxicity using the exact binomial test. Assessments are based on version 5 Common Terminology Criteria for Adverse Events (CTCAE), and the worst severity of GI toxicity will be assessed.

  Up to 3 years

Secondary Outcomes (9)

• Acute grade 2+ genitourinary (GU) toxicity rate

  Up to 3 years

• Optimal frequency of cone beam computed tomography (CT)

  Through study completion, an average of 1 year

• Patient reported health related quality of life (QOL) - PRO-CTCAU GI

  Up to 3 years

• Patient reported health related quality of life (QOL) - PRO-CTCAU GU

  Up to 3 years

• Patient reported health related quality of life (QOL) - IPSS

  Up to 3 years

Study Arms (1)

Treatment (proton beam therapy)

EXPERIMENTAL

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.

Radiation: High-Dose Rate Brachytherapy; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment; Other: Survey Administration

Interventions

High-Dose Rate Brachytherapy RADIATION

Receive high-dose rate brachytherapy boost

Also known as: Brachytherapy, High Dose

Treatment (proton beam therapy)

Proton Beam Radiation Therapy RADIATION

Undergo proton beam therapy

Also known as: PBRT, Proton, Proton Radiation Therapy, Radiation, Proton Beam

Treatment (proton beam therapy)

Survey Administration OTHER

Ancillary studies

Treatment (proton beam therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (proton beam therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy; Proton Therapy; Protons

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Heavy Ion Radiotherapy; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Pretesh R Patel

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pretesh Patel, MD

CONTACT

404-778-3473; pretesh.patel@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 27, 2021
• Study Start: February 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)