Clinical Trials /

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

NCT02470897

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT02470897

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: UW14083
  • SECONDARY ID: NCI-2015-00950
  • SECONDARY ID: 2015-0395
  • SECONDARY ID: UW14083
  • SECONDARY ID: A533300
  • SECONDARY ID: SMPH\HUMAN ONCOLOGY\HUMAN ONCO
  • SECONDARY ID: Protocol Version 1/29/2021
  • NCT ID: NCT02470897

Conditions

  • Stage I Prostate Adenocarcinoma
  • Stage II Prostate Adenocarcinoma

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm A (moderate dose SBRT with SIB)ExperimentalPatients 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 B (uniform dose SBRT)Active ComparatorPatients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning. SBRT: 7.5Gy conventional dose

      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
      Maximum Eligible Age:N/A
      Minimum Eligible Age:N/A
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Incidence of GU and GI Acute Toxicity
      Time Frame:Up to 90 days
      Safety Issue:
      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.

      Secondary Outcome Measures

      Measure:Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment
      Time Frame:at Baseline, 1 year, and 2 years
      Safety Issue:
      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.
      Measure:Change in American Urological Association Symptom Score (AUASS)
      Time Frame:at Baseline, 1 year, and 2 years
      Safety Issue:
      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.
      Measure:Change in International Index of Erectile Dysfunction Questionnaire (IIEF-5)
      Time Frame:at Baseline, 1 year, and 2 years
      Safety Issue:
      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.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:University of Wisconsin, Madison

      Last Updated

      August 18, 2021