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

Clinicaltrials.gov ID: NCT04725903
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 30

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

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Pretesh R Patel

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

Study Plan

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

    Description:

    Receive high-dose rate brachytherapy boost
  • RADIATION:

    Proton Beam Radiation Therapy

    Description:

    Undergo proton beam therapy
  • OTHER:

    Quality-of-Life Assessment

    Description:

    Ancillary studies
  • OTHER:

    Survey Administration

    Description:

    Ancillary studies

Outcome Measures

Primary Outcome Measures

Acute grade 2+ gastrointestinal (GI) toxicity

Time Frame: Up to 3 years

Secondary Outcome Measures

Acute grade 2+ genitourinary (GU) toxicity rate

Time Frame: Up to 3 years

Optimal frequency of cone beam computed tomography (CT)

Time Frame: Through study completion, an average of 1 year

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

Time Frame: Up to 3 years

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

Time Frame: Up to 3 years

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

Time Frame: Up to 3 years

Patient reported health related quality of life (QOL) - EPIC-CP

Time Frame: Up to 3 years

Chronic GI Toxicity

Time Frame: Up to 3 years

Chronic GU Toxicity

Time Frame: Up to 3 years

Biochemical failure

Time Frame: Baseline up to pre-RT

Timeline

  • Last Updated
    November 14, 2024
  • Start Date
    January 27, 2021
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    December 31, 2026

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