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

Sponsor
Emory University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04725903
Collaborator
National Cancer Institute (NCI) (NIH)
30
Enrollment
1
Location
1
Arm
26.9
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase II trial investigates whether proton radiation therapy directed to the prostate tumor and nearby lymph nodes, is an effective way to treat patients with high-risk 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. The information learned from this study may also help researchers to learn more about proton therapy for the treatment of patients with prostate cancer.

Condition or DiseaseIntervention/TreatmentPhase
  • Radiation: High-Dose Rate Brachytherapy
  • Radiation: Proton Beam Radiation Therapy
  • Other: Quality-of-Life Assessment
  • Other: Survey Administration
N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. To determine the rate of acute grade 2+ gastrointestinal toxicity compared to historical photon treatments.
SECONDARY OBJECTIVES:
  1. To determine the rate of acute grade 2+ genitourinary toxicity compared to historical photon treatments.

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

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

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

OUTLINE:

Patients undergo pelvic proton beam therapy daily on Monday-Friday for 8-9 weeks. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Extended-Field Lymph Node Proton Irradiation for High Risk Prostate Cancer
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Treatment (proton beam therapy)

Patients undergo pelvic proton beam therapy daily on Monday-Friday for 8-9 weeks. Patients may receive an optional high-dose rate brachytherapy boost.

Radiation: High-Dose Rate Brachytherapy
Receive high-dose rate brachytherapy boost
Other Names:
  • Brachytherapy, High Dose
  • Radiation: Proton Beam Radiation Therapy
    Undergo proton beam therapy
    Other Names:
  • PBRT
  • Proton
  • Proton Radiation Therapy
  • Radiation, Proton Beam
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Survey Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Acute grade 2+ gastrointestinal (GI) toxicity [Up to 3 years]

      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.

    Secondary Outcome Measures

    1. Acute grade 2+ genitourinary (GU) toxicity rate [Up to 3 years]

      The rate of grade 2+ genitourinary toxicity within 30 days of receiving radiation therapy (RT) will be measured. Assessments are based on version 5 CTCAE, and the worst severity of GU toxicity will also be assessed.

    2. Optimal frequency of cone beam computed tomography (CT) [Through study completion, an average of 1 year]

      Will determine the optimal frequency of cone beam CT during treatment and assess subsequent need for adaptive re-planning. The feasibility of extended-field proton irradiation of high-risk prostate cancer will be estimated using a re-planning rate of less than 10%. The re-planning rate will be estimated as binary variable, yes or no. The exact 95% confidence interval (CI) around the 10 % re-planning count based on the binomial distribution for the estimated 30 patients will be used (0.021-0.265). The study will be deemed feasible if the observed rate is not higher than the upper bound of the estimated 95% CI.

    3. Patient reported health related quality of life (QOL) - PRO-CTCAU GI [Up to 3 years]

      Assessed using Patient Reported Outcomes-CTCAE GI toxicity

    4. Patient reported health related quality of life (QOL) - PRO-CTCAU GU [Up to 3 years]

      Assessed using Patient Reported Outcomes-CTCAE GU toxicity

    5. Patient reported health related quality of life (QOL) - IPSS [Up to 3 years]

      International Prostate Symptom Score (IPSS)

    6. Patient reported health related quality of life (QOL) - EPIC-CP [Up to 3 years]

      Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)

    7. Chronic GI Toxicity [Up to 3 years]

      The rate of any grade gastrointestinal toxicity occurring after 90 days from the completion of radiation therapy(RT). Assessments are based on version 5 Common Terminology Criteria for Adverse Events (CTCAE), and the worst severity of GI toxicity will be assessed.

    8. Chronic GU Toxicity [Up to 3 years]

      The rate of any grade genitourinary toxicity occurring after 90 days from the completion of radiation therapy(RT). Assessments are based on version 5 Common Terminology Criteria for Adverse Events (CTCAE), and the worst severity of GU toxicity will be assessed.

    9. Biochemical failure [Baseline up to pre-RT]

      Assessed by the Phoenix definition (prostate specific antigen [PSA] >= 2 ng/ml over the nadir PSA).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    • Absence of bone metastasis by CT, MRI, bone scan or metabolic imaging (e.g. F-18 sodium fluoride positron emission tomography [NaF PET], anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid [FACBC] PET, etc) within 90 days prior to registration

    • Absence of distant lymph node metastasis

    • Zubrod performance status 0-2

    • Complete blood cell (CBC)/differential obtained within 60 days prior to registration on study

    • 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:
    • Distant metastasis

    • 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Emory University Hospital/Winship Cancer InstituteAtlantaGeorgiaUnited States30322

    Sponsors and Collaborators

    • Emory University
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Pretesh R Patel, Emory University Hospital/Winship Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pretesh Patel, Principal Investigator, Emory University
    ClinicalTrials.gov Identifier:
    NCT04725903
    Other Study ID Numbers:
    • STUDY00000329
    • NCI-2020-07113
    • RAD5131-20
    • P30CA138292
    First Posted:
    Jan 27, 2021
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2022