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

NCT02470897 | Completed DMC FDA Device

• 6 other identifiers: UW14083NCI-2015-009502015-0395A533300SMPH\HUMAN ONCOLOGY\HUMAN ONCOProtocol Version 11/8/2023
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 3

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.

Conditions

Stage I Prostate Adenocarcinoma; Stage II Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment

  at Baseline, 1 year, and 2 years

• Change in American Urological Association Symptom Score (AUASS)

  at Baseline, 1 year, and 2 years

• Change in International Index of Erectile Dysfunction Questionnaire (IIEF-5)

  at Baseline, 1 year, and 2 years

Study Arms (2)

Arm A (moderate dose SBRT with SIB)

EXPERIMENTAL

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; Radiation: SBRT

Arm B (uniform dose SBRT)

ACTIVE COMPARATOR

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; Radiation: SBRT

Interventions

Radiation Therapy Treatment Planning and Simulation RADIATION

Undergo urethral-sparing IMRT planning

Also known as: Radiation Therapy Treatment Planning/Simulation

Arm A (moderate dose SBRT with SIB); Arm B (uniform dose SBRT)

SBRT RADIATION

Undergo moderate dose SBRT with SIB

Also known as: Stereotactic Body Radiation Therapy

Arm A (moderate dose SBRT with SIB)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (3)

Swedish American

Rockford, Illinois, 61104, United States

Location

UW Cancer Center, Johnson Creek

Johnson Creek, Wisconsin, 53038, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Zachary Morris

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 12, 2015
• Study Start: July 24, 2015
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

US (3)