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Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate Cancer

Primary Purpose

Stage I Prostate Adenocarcinoma, Stage II Prostate Adenocarcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy Treatment Planning and Simulation
SBRT
SBRT
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage I Prostate Adenocarcinoma

Eligibility Criteria

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Inclusion Criteria:

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate and most recent biopsy within 180 days of study enrollment
  • History/physical examination with digital rectal examination of the prostate within 90 days prior to study enrollment
  • Gleason score =< 7, no tertiary pattern >= 5
  • Clinical stage =< T2b (American Joint Committee on Cancer [AJCC] 7th Edition Staging Manual) and no radiographic evidence of T3 or T4 disease
  • Clinical stage N0, M0
  • Most recent prostate specific antigen (PSA) within 60 days of enrollment
  • Maximum PSA =< 20 ng/ml (not within 20 days after biopsy)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • American Urological Association (AUA) =< 18 with or without medical management
  • Up to a total of year of androgen deprivation allowed.
  • Participant signs study specific informed consent prior to study enrollment

Exclusion Criteria:

  • FOR ARM A: Inability to obtain a planning MRI or a planning MRI of sufficient quality to allow identification of the peripheral zone and urethra, or inability to adequately fuse the MRI to the planning CT scan
  • FOR BOTH ARM A AND ARM B:
  • Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years; (for example, carcinoma in situ of the bladder or oral cavity is permissible)
  • Prosthetic implants in the pelvic region that the investigator feels will impede treatment, planning, or delivery (e.g., an artificial hip)
  • =< 3 months from a transurethral resection of the prostate (TURP) procedure
  • Significant urinary obstruction (i.e. AUA symptom score > 18)
  • Previous pelvic irradiation, prostate brachytherapy
  • Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

  • Severe, active comorbidity, defined as follows:

    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Crohn's disease or ulcerative colitis
    • Scleroderma

Sites / Locations

  • Swedish American
  • UW Cancer Center, Johnson Creek
  • University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (moderate dose SBRT with SIB)

Arm B (uniform dose SBRT)

Arm Description

Patients undergo 5 fractions of moderate dose SBRT with SIB every other day for 10 days following urethral-sparing IMRT planning. SBRT: 8.0Gy escalated dose

Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning. SBRT: 7.5Gy conventional dose

Outcomes

Primary Outcome Measures

Incidence of GU and GI Acute Toxicity
Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for any added grade 3 rectal toxicity with the use of a simultaneous integrated boost.
Incidence of GU and GI Late Toxicity
Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for any added grade 3 rectal toxicity with the use of a simultaneous integrated boost. A late adverse event will be defined as an adverse event occurring more than 90 days from the completion of RT.
Disease-free survival as measured by the Phoenix definition

Secondary Outcome Measures

Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment
The EPIC 26 assessment has a total range of possible scores of 1-100 where higher scores indicate higher satisfaction. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
Change in American Urological Association Symptom Score (AUASS)
The AUASS has a total possible range of scores of 0-35 where 1-7 is considered mild symptoms, 8-19 is considered moderate symptoms, and 20-35 is considered severe symptoms. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
Change in International Index of Erectile Dysfunction Questionnaire (IIEF-5)
The IIEF-5 questionnaire has a total score of 1-25 where 1-7 is considered severe erectile dysfunction (ED), 8-11 is moderate ED, 12-16 is mild-moderate ED, 17-21 is mild ED, and 22-25 is no ED. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.

Full Information

First Posted
June 10, 2015
Last Updated
July 17, 2023
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT02470897
Brief Title
Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate Cancer
Official Title
A Phase I/II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Simultaneous Integrated Boost and Urethral-Sparing IMRT Planning
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 24, 2015 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

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 I/II trial studies the side effects and best dose of stereotactic body radiation therapy while using intensity-modulated radiation therapy (IMRT) planning to help avoid radiation to normal tissue in patients with prostate cancer. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using small, high doses of radiation over several days and may cause less damage to normal tissue. This treatment schedule allows for a higher dose of radiation to be administered over a shorter overall treatment period in comparison to standard radiation therapy.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the incidence of genitourinary (GU) and gastrointestinal (GI) acute and late toxicity for patients treated with prostate stereotactic body radiotherapy (SBRT) with simultaneous integrative boost, urethral ring sparing, and enhanced prostate localization (magnetic resonance imaging [MRI\-computed tomography [CT] fusion). II. To also evaluate the incidence of GU and GI acute and late toxicity for patients treated with prostate stereotactic body radiotherapy (SBRT) with a more conventional and uniformly delivered dose of 7.25 Gy/fraction to the prostate. III. Disease-free survival: disease-free failure events include local progression, distant progression, biochemical failure as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, and death from any cause. SECONDARY OBJECTIVES: I. Evaluate patient quality of life (QOL) using the Expanded Prostate Cancer Index Composite 26 (EPIC-26) for evaluation of the QOL for up to 3 years after the completion of SBRT. OUTLINE: Participants are assigned to 1 of 2 treatment arms. Participants unable to undergo MRI, whose MRI proves technically inadequate for delineating needed anatomic structures, or who decline to enroll on Arm A are assigned to Arm B. ARM A: (n = 120) Participants undergo 5 fractions of moderate dose SBRT with simultaneous integrated boost (SIB) every other day for 10 days following urethral-sparing IMRT planning. ARM B: (n = 40) Participants undergo 5 fractions of uniform dose SBRT every other day for 10 days following undergo urethral-sparing IMRT planning. After completion of study treatment, patients are followed up at 4-8 weeks, at 4, 8, and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then every 12 months thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Prostate Adenocarcinoma, Stage II Prostate Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (moderate dose SBRT with SIB)
Arm Type
Experimental
Arm Description
Patients undergo 5 fractions of moderate dose SBRT with SIB every other day for 10 days following urethral-sparing IMRT planning. SBRT: 8.0Gy escalated dose
Arm Title
Arm B (uniform dose SBRT)
Arm Type
Active Comparator
Arm Description
Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning. SBRT: 7.5Gy conventional dose
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy Treatment Planning and Simulation
Other Intervention Name(s)
Radiation Therapy Treatment Planning/Simulation
Intervention Description
Undergo urethral-sparing IMRT planning
Intervention Type
Radiation
Intervention Name(s)
SBRT
Other Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
Undergo moderate dose SBRT with SIB
Intervention Type
Radiation
Intervention Name(s)
SBRT
Other Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
Undergo uniform dose SBRT
Primary Outcome Measure Information:
Title
Incidence of GU and GI Acute Toxicity
Description
Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for any added grade 3 rectal toxicity with the use of a simultaneous integrated boost.
Time Frame
Up to 90 days
Title
Incidence of GU and GI Late Toxicity
Description
Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for any added grade 3 rectal toxicity with the use of a simultaneous integrated boost. A late adverse event will be defined as an adverse event occurring more than 90 days from the completion of RT.
Time Frame
Up to 60 months
Title
Disease-free survival as measured by the Phoenix definition
Time Frame
Up to 60 months
Secondary Outcome Measure Information:
Title
Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment
Description
The EPIC 26 assessment has a total range of possible scores of 1-100 where higher scores indicate higher satisfaction. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
Time Frame
at Baseline, 1 year, and 2 years
Title
Change in American Urological Association Symptom Score (AUASS)
Description
The AUASS has a total possible range of scores of 0-35 where 1-7 is considered mild symptoms, 8-19 is considered moderate symptoms, and 20-35 is considered severe symptoms. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
Time Frame
at Baseline, 1 year, and 2 years
Title
Change in International Index of Erectile Dysfunction Questionnaire (IIEF-5)
Description
The IIEF-5 questionnaire has a total score of 1-25 where 1-7 is considered severe erectile dysfunction (ED), 8-11 is moderate ED, 12-16 is mild-moderate ED, 17-21 is mild ED, and 22-25 is no ED. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
Time Frame
at Baseline, 1 year, and 2 years

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of adenocarcinoma of the prostate and most recent biopsy within 180 days of study enrollment History/physical examination with digital rectal examination of the prostate within 90 days prior to study enrollment Gleason score =< 7, no tertiary pattern >= 5 Clinical stage =< T2b (American Joint Committee on Cancer [AJCC] 7th Edition Staging Manual) and no radiographic evidence of T3 or T4 disease Clinical stage N0, M0 Most recent prostate specific antigen (PSA) within 60 days of enrollment Maximum PSA =< 20 ng/ml (not within 20 days after biopsy) Eastern Cooperative Oncology Group (ECOG) performance status 0-1 American Urological Association (AUA) =< 18 with or without medical management Up to a total of year of androgen deprivation allowed. Participant signs study specific informed consent prior to study enrollment Exclusion Criteria: FOR ARM A: Inability to obtain a planning MRI or a planning MRI of sufficient quality to allow identification of the peripheral zone and urethra, or inability to adequately fuse the MRI to the planning CT scan FOR BOTH ARM A AND ARM B: Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years; (for example, carcinoma in situ of the bladder or oral cavity is permissible) Prosthetic implants in the pelvic region that the investigator feels will impede treatment, planning, or delivery (e.g., an artificial hip) =< 3 months from a transurethral resection of the prostate (TURP) procedure Significant urinary obstruction (i.e. AUA symptom score > 18) Previous pelvic irradiation, prostate brachytherapy Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer Severe, active comorbidity, defined as follows: Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration Crohn's disease or ulcerative colitis Scleroderma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary Morris
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish American
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61104
Country
United States
Facility Name
UW Cancer Center, Johnson Creek
City
Johnson Creek
State/Province
Wisconsin
ZIP/Postal Code
53038
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center

Learn more about this trial

Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate Cancer

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