Recruiting

Proton Radiation Therapy

Sponsor:

Emory University

Code:

NCT04725903

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

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High-Dose Rate Brachytherapy

Proton Beam Radiation Therapy

Quality-of-Life Assessment

Survey Administration

Study Details

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

Study ID

NCT04725903

Start date

Feb 1, 2021

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

High-Dose Rate Brachytherapy

Receive high-dose rate brachytherapy boost

Proton Beam Radiation Therapy

Undergo proton beam therapy

Quality-of-Life Assessment

Ancillary studies

Survey Administration

Ancillary studies

Primary outcome measure

  • Acute grade 2+ gastrointestinal (GI) toxicity [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Pretesh Patel, MD

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

Locations

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Ardith R. DeShay

404-686-1858adeshay@emory.edu

Principal Investigator:

Pretesh R. Patel, MD

More Information

Sponsor

Emory University

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-02-17.