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

  • STATUS
    Recruiting
  • End date
    May 1, 2023
  • participants needed
    30
  • sponsor
    Emory University
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Updated on 4 October 2022
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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.

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.

Details
Condition Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
Treatment quality-of-life assessment, survey administration, Proton Beam Radiation Therapy, High-Dose Rate Brachytherapy
Clinical Study IdentifierNCT04725903
SponsorEmory University
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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
Complete blood cell (CBC)/differential obtained within 90 days prior to registration on study
Zubrod performance status 0-2
Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 60 days prior to registration on study)
Platelets >= 100,000 cells/mm^3 (obtained within 60 days prior to registration on study)
Hemoglobin >= 8.0 g/dl (obtained within 60 days prior to registration on study) (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.) within 90 days prior to registration
Absence of distant lymph node metastasis by CT and/or MRI within 90 days prior to registration
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
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