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

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ClinicalTrials.gov Identifier: NCT02470897
Recruitment Status : Recruiting
First Posted : June 12, 2015
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE June 10, 2015
First Posted Date  ICMJE June 12, 2015
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE July 24, 2015
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2019)
  • Incidence of GU and GI Acute Toxicity [ Time Frame: Up to 90 days ]
    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 [ Time Frame: Up to 60 months ]
    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 [ Time Frame: Up to 60 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
  • Biochemical disease-free survival as measured by the Phoenix definition [ Time Frame: Up to 12 months ]
    Patients will be considered to be without biochemical recurrence if either the PSA is still declining or the PSA has not risen above its nadir by >= 2 ng/ml, and there is no palpable or radiologic evidence of disease. Patients will be judged to have progressive or recurrent disease if they meet the Phoenix nadir plus 2 ng/ml definition of biochemical failure, display clinical evidence of local or distant progression of disease, or have a positive prostate re-biopsy.
  • Biochemical disease-free survival as measured by the Phoenix definition [ Time Frame: Up to 60 months ]
    Patients will be considered to be without biochemical recurrence if either the PSA is still declining or the PSA has not risen above its nadir by >= 2 ng/ml, and there is no palpable or radiologic evidence of disease. Patients will be judged to have progressive or recurrent disease if they meet the Phoenix nadir plus 2 ng/ml definition of biochemical failure, display clinical evidence of local or distant progression of disease, or have a positive prostate re-biopsy.
  • Cause-specific survival [ Time Frame: Up to 60 months ]
  • Disease-free survival [ Time Frame: Up to 60 months ]
    Disease-free failure events include local progression, distant progression biochemical failure as defined by the RTOG Phoenix definition, and death from any cause.
  • Incidence of acute (=< 90 days) GI toxicities, scored according to the modified Fox Chase Late Effects Normal Tissue (FC-LENT) criteria [ Time Frame: Up to 90 days ]
    Both unadjusted and adjusted odds ratios and the respective 95% confidence interval will be computed.
  • Incidence of acute (=< 90 days) GU toxicities, scored according to the modified RTOG criteria [ Time Frame: Up to 90 days ]
    Both unadjusted and adjusted odds ratios and the respective 95% confidence interval will be computed.
  • Incidence of early adverse events, defined as an adverse event occurring less than or equal to 90 days from completion of RT, scored according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v.)4.0 (general, unexpected) criteria [ Time Frame: Up to 90 days ]
    Both unadjusted and adjusted odds ratios and the respective 95% confidence interval will be computed.
  • Incidence of late (> 90 days) GI toxicities, scored according to the modified FC-LENT criteria [ Time Frame: Up to 60 months ]
    Both unadjusted and adjusted odds ratios and the respective 95% confidence interval will be computed.
  • Incidence of late (> 90 days) GU toxicities, scored according to the modified RTOG criteria [ Time Frame: Up to 60 months ]
    Both unadjusted and adjusted odds ratios and the respective 95% confidence interval will be computed.
  • Metastasis-free survival [ Time Frame: Up to 60 months ]
  • Time to late adverse events, defined as an adverse event occurring more than 90 days from the completion of RT, scored according to the CTCAE v.4.0 (general, unexpected) criteria [ Time Frame: From the time that protocol treatment is completed (i.e., the completion of radiation) to the time of the worst late adverse event, assessed up to 60 months ]
    The distribution of time to late adverse events (observed severities of adverse events over time) will be estimated.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2019)
  • Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment [ Time Frame: at Baseline, 1 year, and 2 years ]
    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) [ Time Frame: at Baseline, 1 year, and 2 years ]
    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) [ Time Frame: at Baseline, 1 year, and 2 years ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
  • Erectile function, assessed using the International Index of Erectile Function Questionnaire [ Time Frame: Up to 3 years ]
  • Overall QOL, assessed using EPIC 26 quality of life assessment [ Time Frame: Up to 3 years ]
  • Urinary QOL, assessed with the AUA Symptom Score (SS) questionnaire [ Time Frame: Up to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate Cancer
Official Title  ICMJE A Phase I/II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Simultaneous Integrated Boost and Urethral-Sparing IMRT Planning
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stage I Prostate Adenocarcinoma
  • Stage II Prostate Adenocarcinoma
Intervention  ICMJE
  • Radiation: Radiation Therapy Treatment Planning and Simulation
    Undergo urethral-sparing IMRT planning
    Other Name: Radiation Therapy Treatment Planning/Simulation
  • Radiation: SBRT
    Undergo moderate dose SBRT with SIB
    Other Name: Stereotactic Body Radiation Therapy
  • Radiation: SBRT
    Undergo uniform dose SBRT
    Other Name: Stereotactic Body Radiation Therapy
Study Arms  ICMJE
  • 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

    Interventions:
    • Radiation: Radiation Therapy Treatment Planning and Simulation
    • Radiation: SBRT
  • 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

    Interventions:
    • Radiation: Radiation Therapy Treatment Planning and Simulation
    • Radiation: SBRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2015)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Confirmation that insurance will cover SBRT through normal hospital authorization process

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cancer Connect (800) 622-8922 clinicaltrials@cancer.wisc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02470897
Other Study ID Numbers  ICMJE UW14083
NCI-2015-00950 ( Registry Identifier: NCI Trial ID )
2015-0395 ( Other Identifier: Institutional Review Board )
UW14083 ( Other Identifier: University of Wisconsin Carbone Cancer Center )
A533300 ( Other Identifier: UW Madison )
SMPH\HUMAN ONCOLOGY\HUMAN ONCO ( Other Identifier: UW Madison )
Protocol Version 5/22/2020 ( Other Identifier: UW Madison )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zachary Morris University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP