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

A Phase I/II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Simultaneous Integrated Boost and Urethral-Sparing IMRT Planning

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stage II Prostate Adenocarcinoma; Stage I Prostate Adenocarcinoma
• Intervention / Treatment: Radiation: Radiation Therapy Treatment Planning and Simulation; Radiation: SBRT; Radiation: SBRT

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.

Per protocol amendment in December 2023, the follow up time period for data collection will change to 3 years after the last participant completed treatment.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Rockford, Illinois, United States, 61104
      • Swedish American
  • Wisconsin
    • Johnson Creek, Wisconsin, United States, 53038
      • UW Cancer Center, Johnson Creek
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (moderate dose SBRT with SIB); 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	Radiation: Radiation Therapy Treatment Planning and Simulation; Undergo urethral-sparing IMRT planning; Other Names: Radiation Therapy Treatment Planning/Simulation; Radiation: SBRT; Undergo moderate dose SBRT with SIB; Other Names: Stereotactic Body Radiation Therapy; Radiation: SBRT; Undergo uniform dose SBRT; Other Names: Stereotactic Body Radiation Therapy
Active Comparator: Arm B (uniform dose SBRT); Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning. SBRT: 7.5Gy conventional dose	Radiation: Radiation Therapy Treatment Planning and Simulation; Undergo urethral-sparing IMRT planning; Other Names: Radiation Therapy Treatment Planning/Simulation; Radiation: SBRT; Undergo moderate dose SBRT with SIB; Other Names: Stereotactic Body Radiation Therapy; Radiation: SBRT; Undergo uniform dose SBRT; Other Names: Stereotactic Body Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 90 days
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.	Up to 3 years
Disease-free survival as measured by the Phoenix definition		Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at Baseline, 1 year, and 2 years
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.	at Baseline, 1 year, and 2 years
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.	at Baseline, 1 year, and 2 years

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Zachary Morris, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2015
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimated): June 12, 2015

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Adenocarcinoma
• Other Study ID Numbers: UW14083 (Other Identifier: University of Wisconsin Carbone Cancer Center); A533300 (Other Identifier: UW Madison); SMPH\HUMAN ONCOLOGY\HUMAN ONCO (Other Identifier: UW Madison); NCI-2015-00950 (Registry Identifier: NCI Trial ID); 2015-0395 (Other Identifier: Institutional Review Board); Protocol Version 11/8/2023 (Other Identifier: UW Madison)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes