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Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer (PR11)

Primary Purpose

Adenocarcinoma of the Prostate

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HR-A
HR-B
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate focused on measuring High-risk, Prostate cancer, Proton Radiation, Dose-escalated, Hypofractionation, Simultaneous Integrated Boost (SIB), Intraprostatic Tumor (IPT), Proton Therapy (PT), Androgen Deprivation Therapy (ADT), Magnetic Resonance Imaging (MRI)

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment.
  • Patient must be at least 18 years at the time of consent.
  • Adenocarcinoma of the prostate with AJCC Clinical Stage T1to T3b disease with histological evaluation via biopsy or repeat biopsy within 12 months prior to registration.
  • Patients must undergo a pretreatment diagnostic MRI of the prostate on a 1.5T to 3T Tesla machine within 6 months prior to study registration.
  • A focal IPT must be visible on MRI within the prostate and/or seminal vesicles and this MRI must be obtained within 6 months of planning CT scan.
  • A biopsy of the dominant lesion is recommended but not required. If an ultrasound guided sextant biopsy was positive for prostatic adenocarcinoma in the area of the MRI identified intraprostatic lesion, this will be acceptable and another guided biopsy targeting the MRI identified disease will not be necessary.
  • Patients with at least one of the following high-risk factors: cT3a-T3b OR Gleason 9-10 OR PSA > 30 OR more than 1 high-risk factors must be present: clinical stage of T3, Gleason score 8-10, or PSA 20 ng/ml or greater.
  • Hemoglobin must be ≥ 10 g/ml within 4 months prior to registration.
  • Zubrod performance status must be 0-1 within 4 months prior to registration.
  • If patient has child-producing potential, they must be willing to use medically acceptable contraception during treatment and must be advised to use it for at least 1 year thereafter. This is not applicable if the patient is not sexually active or has had a vasectomy.
  • Patients must be able to start treatment within 16 weeks of registration.

Exclusion Criteria:

  • T4 prostate disease on CT, MRI, or physical exam.
  • Patients unable to undergo MRI of the prostate.
  • Patients with a greater than 25% change in prostate volume from the pretreatment MRI of the prostate demonstrating the IPT and the treatment planning MRI. Patients in this case must undergo a repeat diagnostic MRI on a 1.5T to 3.0T Tesla machine and an IPT must still be visible.
  • IPT that is more than 75% of the prostate volume when measured on the CT simulation scan.
  • Evidence of distant metastasis (M1).
  • Patients with positive nodes on cross-sectional imaging.
  • Previous prostate cancer local treatment including prostatectomy, hyperthermia, high intensity focused ultrasound, brachytherapy, external-beam radiation therapy, and/or cryotherapy.
  • Prior pelvic radiation therapy.
  • No prior myocardial infarction within the last 6 months, severe congestive heart failure, or end stage renal disease.
  • Active inflammatory bowel disease (diverticulitis, Crohn's disease, ulcerative colitis) affecting the rectum.
  • Bilateral hip replacement
  • Prior intrapelvic surgery. This includes the following:

    • Bladder surgery

  • Prior transurethral resection of the prostate (TURP) or laser ablation for benign prostatic hyperplasia (BPH).
  • Patients receiving continuous and current anticoagulation with warfarin sodium (Coumadin), heparin sodium, clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), enoxaparin sodium (Lovenox), prasugrel (Effient), ticagrelor (Brilinta), aspirin/er dipyridamole (Aggrenox), or fondaparinux sodium (Arixtra).

Sites / Locations

  • University of Florida Health Proton Therapy InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HR-A (High-risk A)

HR-B (High-risk B)

Arm Description

Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 78 cobalt gray equivalent. Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent.

Prostate, proximal seminal vesicles, and pelvic nodes: 2 cobalt gray equivalent per fraction to a total does of 46 cobalt gray equivalent. Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 32 cobalt gray equivalent. Entire uninvolved seminal vesicle when part of the seminal vesicle is involved with tumor: 2 cobalt gray equivalent per fraction to a total dose of 78 cobalt gray equivalent. Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent.

Outcomes

Primary Outcome Measures

Cumulative rate of biochemical failure at 5 years after the end of treatment.
Biochemical failure will be defined based on the Phoenix definition. Biochemical failure has occurred if the post-treatment prostate-specific antigen (PSA) on at least two occasions rose more than 2 ng/ml above the PSA nadir. Rate of biochemical failure will be measured at 5 years after the end of treatment.

Secondary Outcome Measures

Cumulative rate of acute toxicity observed between day 1 of treatment and 90 days after treatment.
Assess physician-graded, severe (Grade 3-4), acute (early, within 90 days of treatment) genitourinary and gastrointestinal toxicity rates based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Cumulative rate of late toxicity observed between 90 days and 5 years after end of treatment.
Assess physician-graded, severe (Grade 3-4), late (beginning 90 or more days after treatment), cumulative 5 year genitourinary and gastrointestinal toxicity rates based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Rate of change in sexual, bowel, and urinary function from baseline measurement to 5 years after end of treatment.
Assess changes in patient-reported quality of life before and after treatment according to The International Index of Erectile Function (IIEF-5/IIEF-5m) which measures sexual function and the effect of radiation therapy; The International Prostate Symptom Score (IPSS) which measures urinary function and the effect of radiation therapy; and The Expanded Prostate Cancer Index Composite (EPIC) which measures different areas that may be affected by prostate cancer or its treatment.
Assessment of overall and disease-free survival
Assess the overall survival, defined as the time from the start of treatment to the date of death of any cause, if data is available, at 5 years. Also, cause-specific survival will be calculated.
Assessment of local persistence or local recurrence
Assess local persistence or local recurrence of prostate cancer at 5 years. Local persistence is defined as the failure of the original abnormal tumor mass seen on cross sectional imaging and/or found on digital rectal exam to resolve in patients who also had a poor PSA response with a PSA nadir greater than 1 ng/mL. Local recurrence is defined as the development of any new abnormal prostate mass on cross sectional imaging or on digital rectal exam with previous exams or imaging showing no mass in the area prior to radiation therapy or after initial treatment.
Rate of distant metastases five years after end of radiation therapy
Assess the cumulative rate development of distant metastasis up to 5 years after end of radiation. This will be an aggregate binary, yes/no response based on evidence acquired from sources including CT scan, bone scan, and/or PET/CT scan.

Full Information

First Posted
July 23, 2018
Last Updated
September 15, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03624660
Brief Title
Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer
Acronym
PR11
Official Title
A Phase II Study of Dose-Escalated Proton-Based Radiation Therapy Delivered With a Simultaneous Integrated Boost (SIB) to Intraprostatic Tumors (IPT) Visible on Pretreatment Magnetic Resonance Image
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
September 2028 (Anticipated)
Study Completion Date
September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this research study is to determine if dose-escalated proton radiation therapy is a good way to treat high-risk prostate cancer. The study features hypofractionation and a simultaneous integrated boost to the magnetic resonance imaging (MRI) identified intraprostatic tumor (IPT) as a method of dose-escalating radiation therapy. The study will include patients with high-risk prostate cancer who are at the highest risk for recurrence. Radiation therapy will be delivered over the course of 8-9 weeks. Additionally, androgen deprivation therapy (ADT) will be started 8-10 weeks prior to starting radiation and continued for a total of 18 months if the patient decides to receive ADT.
Detailed Description
Prostate cancer is the most common noncutaneous cancer among men in the United States. The purpose of this research study is to determine if dose-escalated proton radiation therapy is a good way to treat high-risk prostate cancer. Proton therapy (PT) is a type of ionizing radiation therapy that reduces the dose of excess radiation delivered to normal tissues. By escalating the radiation dose just to the area of the known tumor within the prostate, one could potentially reduce the amount of excess radiation delivered to surrounding organs.This reduction in dose would improve the therapeutic ratio by improving disease control while minimizing the risk for additional toxicity. In an effort to take advantage of dose escalation's potential for improving disease control but also to limit toxicity, the use of advanced imaging to identify prostate cancer and provide a focal radiation boost to the area have proven to be useful. Recent advances in MRI have made it the most promising technique in identifying and targeting IPTs, improving both cancer control rates and decreasing toxicity. The study features hypofractionation and a simultaneous integrated boost to the MRI identified intraprostatic tumor (IPT) as a method of dose-escalating radiation therapy. The study will include patients with high-risk prostate cancer who are at the highest risk for recurrence. Radiation therapy will be delivered over the course of 8-9 weeks. Additionally, androgen deprivation therapy (ADT) will be started 8-10 weeks prior to starting radiation and continued for a total of 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate
Keywords
High-risk, Prostate cancer, Proton Radiation, Dose-escalated, Hypofractionation, Simultaneous Integrated Boost (SIB), Intraprostatic Tumor (IPT), Proton Therapy (PT), Androgen Deprivation Therapy (ADT), Magnetic Resonance Imaging (MRI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be assigned to treatment group according to their lymph node risk or seminal vesicle invasion. 2 treatment groups: HR-A: Patients with <15% risk of positive pelvic nodes, without posterior extracapsular extension and negative for seminal vesicle invasion on exam pretreatment diagnostic MRI. HR-B: Patient with ≥ 15% risk of positive pelvic nodes or with seminal vesicle invasion, without posterior extracapsular extension.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HR-A (High-risk A)
Arm Type
Experimental
Arm Description
Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 78 cobalt gray equivalent. Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent.
Arm Title
HR-B (High-risk B)
Arm Type
Experimental
Arm Description
Prostate, proximal seminal vesicles, and pelvic nodes: 2 cobalt gray equivalent per fraction to a total does of 46 cobalt gray equivalent. Prostate and proximal seminal vesicles: 2 cobalt gray equivalent per fraction to a total dose of 32 cobalt gray equivalent. Entire uninvolved seminal vesicle when part of the seminal vesicle is involved with tumor: 2 cobalt gray equivalent per fraction to a total dose of 78 cobalt gray equivalent. Simultaneous integrated boost to the IPT: 2.2 cobalt gray equivalent per fraction to a total dose of 85.8 cobalt gray equivalent.
Intervention Type
Radiation
Intervention Name(s)
HR-A
Other Intervention Name(s)
Proton Radiation
Intervention Description
The prostate and proximal seminal vesicles will be treated to 2 cobalt gray equivalent per fraction for 39 fractions for a total of 78 cobalt gray equivalent. Simultaneous integrated boost to the IPT will be delivered to 2.2 cobalt gray equivalent per fraction for 39 fractions for a total of 85.8 cobalt gray equivalent. Treatment will be given once a day, approximately 5 treatments per week (Monday- Friday), over 8-9 weeks.
Intervention Type
Radiation
Intervention Name(s)
HR-B
Other Intervention Name(s)
Proton Radiation
Intervention Description
The prostate, proximal seminal vesicles, and pelvic nodes will be treated to 2 cobalt gray equivalent per fraction for 23 fractions for a total of 46 cobalt gray equivalent. The prostate and proximal seminal vesicles will be treated to an additional 2 cobalt gray equivalent per fraction for 16 fractions for a total of 32 cobalt gray equivalent. Electively treat the entire uninvolved seminal vesicle to 2 cobalt gray equivalent per fraction for 39 fractions for a total of 78 cobalt gray equivalent when part of the seminal vesicle is involved with tumor. Simultaneous integrated boost to the IPT will be delivered to 2.2 cobalt gray equivalent per fraction for 39 fractions for a total of 85.8 cobalt gray equivalent. Treatment will be given once a day, approximately 5 treatments per week (Monday- Friday), over 8-9 weeks.
Primary Outcome Measure Information:
Title
Cumulative rate of biochemical failure at 5 years after the end of treatment.
Description
Biochemical failure will be defined based on the Phoenix definition. Biochemical failure has occurred if the post-treatment prostate-specific antigen (PSA) on at least two occasions rose more than 2 ng/ml above the PSA nadir. Rate of biochemical failure will be measured at 5 years after the end of treatment.
Time Frame
5 years after the end of radiation therapy
Secondary Outcome Measure Information:
Title
Cumulative rate of acute toxicity observed between day 1 of treatment and 90 days after treatment.
Description
Assess physician-graded, severe (Grade 3-4), acute (early, within 90 days of treatment) genitourinary and gastrointestinal toxicity rates based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time Frame
90 days after the end of radiation therapy
Title
Cumulative rate of late toxicity observed between 90 days and 5 years after end of treatment.
Description
Assess physician-graded, severe (Grade 3-4), late (beginning 90 or more days after treatment), cumulative 5 year genitourinary and gastrointestinal toxicity rates based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time Frame
60 months after the end of radiation therapy
Title
Rate of change in sexual, bowel, and urinary function from baseline measurement to 5 years after end of treatment.
Description
Assess changes in patient-reported quality of life before and after treatment according to The International Index of Erectile Function (IIEF-5/IIEF-5m) which measures sexual function and the effect of radiation therapy; The International Prostate Symptom Score (IPSS) which measures urinary function and the effect of radiation therapy; and The Expanded Prostate Cancer Index Composite (EPIC) which measures different areas that may be affected by prostate cancer or its treatment.
Time Frame
Rate of change between baseline measurement and 5 years end of radiation therapy
Title
Assessment of overall and disease-free survival
Description
Assess the overall survival, defined as the time from the start of treatment to the date of death of any cause, if data is available, at 5 years. Also, cause-specific survival will be calculated.
Time Frame
5 years after the end of radiation therapy
Title
Assessment of local persistence or local recurrence
Description
Assess local persistence or local recurrence of prostate cancer at 5 years. Local persistence is defined as the failure of the original abnormal tumor mass seen on cross sectional imaging and/or found on digital rectal exam to resolve in patients who also had a poor PSA response with a PSA nadir greater than 1 ng/mL. Local recurrence is defined as the development of any new abnormal prostate mass on cross sectional imaging or on digital rectal exam with previous exams or imaging showing no mass in the area prior to radiation therapy or after initial treatment.
Time Frame
5 years after the end of radiation therapy
Title
Rate of distant metastases five years after end of radiation therapy
Description
Assess the cumulative rate development of distant metastasis up to 5 years after end of radiation. This will be an aggregate binary, yes/no response based on evidence acquired from sources including CT scan, bone scan, and/or PET/CT scan.
Time Frame
5 years after the end of radiation therapy

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate cancer is gender-specific. Biological males only.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment. Patient must be at least 18 years at the time of consent. Adenocarcinoma of the prostate with AJCC Clinical Stage T1to T3b disease with histological evaluation via biopsy or repeat biopsy within 12 months prior to registration. Patients must undergo a pretreatment diagnostic MRI of the prostate on a 1.5T to 3T Tesla machine within 6 months prior to study registration. A focal IPT must be visible on MRI within the prostate and/or seminal vesicles and this MRI must be obtained within 6 months of planning CT scan. A biopsy of the dominant lesion is recommended but not required. If an ultrasound guided sextant biopsy was positive for prostatic adenocarcinoma in the area of the MRI identified intraprostatic lesion, this will be acceptable and another guided biopsy targeting the MRI identified disease will not be necessary. Patients with at least one of the following high-risk factors: cT3a-T3b OR Gleason 9-10 OR PSA > 30 OR more than 1 high-risk factors must be present: clinical stage of T3, Gleason score 8-10, or PSA 20 ng/ml or greater. Hemoglobin must be ≥ 10 g/ml within 4 months prior to registration. Zubrod performance status must be 0-1 within 4 months prior to registration. If patient has child-producing potential, they must be willing to use medically acceptable contraception during treatment and must be advised to use it for at least 1 year thereafter. This is not applicable if the patient is not sexually active or has had a vasectomy. Patients must be able to start treatment within 16 weeks of registration. Exclusion Criteria: T4 prostate disease on CT, MRI, or physical exam. Patients unable to undergo MRI of the prostate. Patients with a greater than 25% change in prostate volume from the pretreatment MRI of the prostate demonstrating the IPT and the treatment planning MRI. Patients in this case must undergo a repeat diagnostic MRI on a 1.5T to 3.0T Tesla machine and an IPT must still be visible. IPT that is more than 75% of the prostate volume when measured on the CT simulation scan. Evidence of distant metastasis (M1). Patients with positive nodes on cross-sectional imaging. Previous prostate cancer local treatment including prostatectomy, hyperthermia, high intensity focused ultrasound, brachytherapy, external-beam radiation therapy, and/or cryotherapy. Prior pelvic radiation therapy. No prior myocardial infarction within the last 6 months, severe congestive heart failure, or end stage renal disease. Active inflammatory bowel disease (diverticulitis, Crohn's disease, ulcerative colitis) affecting the rectum. Bilateral hip replacement Prior intrapelvic surgery. This includes the following: • Bladder surgery Prior transurethral resection of the prostate (TURP) or laser ablation for benign prostatic hyperplasia (BPH). Patients receiving continuous and current anticoagulation with warfarin sodium (Coumadin), heparin sodium, clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), enoxaparin sodium (Lovenox), prasugrel (Effient), ticagrelor (Brilinta), aspirin/er dipyridamole (Aggrenox), or fondaparinux sodium (Arixtra).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Intake Coordinator
Phone
877-686-6009
Email
jgaskins@floridaproton.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis M Bryant, MD, MPH
Organizational Affiliation
University of Florida Health Proton Therapy Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Health Proton Therapy Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Intake Coordinator
Phone
877-686-6009
First Name & Middle Initial & Last Name & Degree
Curtis M Bryant, MD, MPH

12. IPD Sharing Statement

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Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer

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