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

Primary Purpose

Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Dose Rate Brachytherapy
Proton Beam Radiation Therapy
Quality-of-Life Assessment
Survey Administration
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage III Prostate Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 (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

Sites / Locations

  • Emory University Hospital/Winship Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (proton beam therapy)

Arm Description

Patients undergo conventionally fractionated 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acute grade 2+ genitourinary (GU) toxicity rate
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.
Optimal frequency of cone beam computed tomography (CT)
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.
Patient reported health related quality of life (QOL) - PRO-CTCAU GI
Assessed using Patient Reported Outcomes-CTCAE GI toxicity
Patient reported health related quality of life (QOL) - PRO-CTCAU GU
Assessed using Patient Reported Outcomes-CTCAE GU toxicity
Patient reported health related quality of life (QOL) - IPSS
International Prostate Symptom Score (IPSS)
Patient reported health related quality of life (QOL) - EPIC-CP
Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
Chronic GI Toxicity
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.
Chronic GU Toxicity
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.
Biochemical failure
Assessed by the Phoenix definition (prostate specific antigen [PSA] >= 2 ng/ml over the nadir PSA).

Full Information

First Posted
January 8, 2021
Last Updated
June 14, 2023
Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04725903
Brief Title
Proton Radiation Therapy for the Treatment of Patients With High Risk Prostate Cancer
Official Title
Extended-Field Lymph Node Proton Irradiation for High Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (proton beam therapy)
Arm Type
Experimental
Arm Description
Patients undergo conventionally fractionated 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.
Intervention Type
Radiation
Intervention Name(s)
High-Dose Rate Brachytherapy
Other Intervention Name(s)
Brachytherapy, High Dose
Intervention Description
Receive high-dose rate brachytherapy boost
Intervention Type
Radiation
Intervention Name(s)
Proton Beam Radiation Therapy
Other Intervention Name(s)
PBRT, Proton, Proton Radiation Therapy, Radiation, Proton Beam
Intervention Description
Undergo proton beam therapy
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Acute grade 2+ gastrointestinal (GI) toxicity
Description
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.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Acute grade 2+ genitourinary (GU) toxicity rate
Description
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.
Time Frame
Up to 3 years
Title
Optimal frequency of cone beam computed tomography (CT)
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Patient reported health related quality of life (QOL) - PRO-CTCAU GI
Description
Assessed using Patient Reported Outcomes-CTCAE GI toxicity
Time Frame
Up to 3 years
Title
Patient reported health related quality of life (QOL) - PRO-CTCAU GU
Description
Assessed using Patient Reported Outcomes-CTCAE GU toxicity
Time Frame
Up to 3 years
Title
Patient reported health related quality of life (QOL) - IPSS
Description
International Prostate Symptom Score (IPSS)
Time Frame
Up to 3 years
Title
Patient reported health related quality of life (QOL) - EPIC-CP
Description
Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
Time Frame
Up to 3 years
Title
Chronic GI Toxicity
Description
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.
Time Frame
Up to 3 years
Title
Chronic GU Toxicity
Description
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.
Time Frame
Up to 3 years
Title
Biochemical failure
Description
Assessed by the Phoenix definition (prostate specific antigen [PSA] >= 2 ng/ml over the nadir PSA).
Time Frame
Baseline up to pre-RT

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 (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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pretesh Patel, MD
Phone
404-778-3473
Email
pretesh.patel@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pretesh R Patel
Organizational Affiliation
Emory University Hospital/Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ardith R. DeShay
Phone
404-686-1858
Email
adeshay@emory.edu
First Name & Middle Initial & Last Name & Degree
Pretesh R. Patel, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results of the trial and not individual patient data will be shared. The study protocol, consent, and investigator's brochure will be available. The statistical plan is incorporated into the protocol, along with inclusion and exclusion criteria.

Learn more about this trial

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

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