Clinical Trials /

Ultra-hypofractionated Radiation in Prostate Cancer

NCT03486821

Description:

The primary objective of this study is to demonstrate that ultra-hypofractionation of prostate cancer does not increase urinary toxicity as defined by the EPIC-26 GU domain patient reported outcome.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Ultra-hypofractionated Radiation in Prostate Cancer
  • Official Title: Pilot Trial of Ultra-hypofractionated Radiation in Early Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: IIT-2017-PROS-UltraHypoFracRT
  • NCT ID: NCT03486821

Conditions

  • Early Stage Prostate Cancer

Purpose

The primary objective of this study is to demonstrate that ultra-hypofractionation of prostate cancer does not increase urinary toxicity as defined by the EPIC-26 GU domain patient reported outcome.

Detailed Description

      This is a pilot clinical trial looking at 2 fraction SBRT radiation therapy as an alternative
      to standard of care. Data does not yet exist for the safety and efficacy of this regimen.

      However, the feasibility of ultra-short radiation therapy treatments has already been
      demonstrated in an analogous treatment using high-dose rate (HDR) brachytherapy. HDR
      brachytherapy has been adopted at high volume cancers centers as a standard treatment for
      prostate cancer. Typical doses have been 26 - 27 Gy over 2 fractions (13 or 13.5 Gy per
      fraction). Overall, toxicity and efficacy of HDR brachytherapy have compared favorably to
      other treatment modalities.

      Dosimetric planning models between SBRT and HDR brachytherapy suggest minor differences. HDR
      brachytherapy was able to achieve higher intraprostatic maximum doses and lower rectal doses,
      but target volume coverage and urethral dose was not significantly different. These data
      suggest that reducing SBRT treatments from 5 fractions to 2 fractions may be feasible,
      efficacious and tolerable.

      Eligible patients include all patients who are otherwise eligible for standard 5 fraction
      SBRT prostate. Study population will be low and intermediate patients with good urinary
      function (as defined by small prostate volume and low IPSS score). SBRT treatment will be
      delivered to the prostate to 12.5 Gy x 2 fractions.

      Hormonal therapy is permitted on this study. Permitted agents include: leuprolide
      (Lupron/Eligard), biclutamide (Casodex), and degarelix (Firmagon).

      Rectal sparing with hydrogel spacer (SpaceOAR) will be encouraged.

      All patients will be enrolled with interim safety analyses after every occurrence of a grade
      3 acute or late toxicity. Interval safety analysis will also be performed for recurrence and
      decrease in EPIC GU domain quality of life. Biospecimen and financial toxicity data will also
      be collected.
    

Trial Arms

NameTypeDescriptionInterventions
Hypofrac Radiation TherapyExperimentalAll patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy. Radiation treatment will start approximately 1-2 weeks after the simulation scan. Prior to each treatment, you will be asked to have a full bladder and empty rectum. You will be asked to take a liquid diet starting the afternoon prior to each treatment, and a laxative (such as Miralax) in the evening prior to each treatment. You will also be asked to take a Fleet's enema about 1 hours prior to the treatment time to ensure that the rectum is empty. To ensure full bladder, you will be asked to drink about 32 oz of water after the enema. This is the same procedure as above for the prep before the simulation scan. Each treatment should take about 10-20 minutes.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Ability of participant to sign a written informed consent.
    
              -  Diagnosed with prostate cancer, T1-T2bN0M0 GS6-7, PSA < 20
    
              -  IPSS score < 15 (and < 10 if on medication for benign prostatic hypertrophy such as
                 tamsulosin) at time of enrollment (Appendix 21.4)
    
              -  Prostate volume (by US, CT or MRI measurement) < 50 cc at time of enrollment
    
              -  Androgen deprivation therapy based on clinician judgment is permitted on study
    
              -  Life expectancy > 10 years based on clinician's judgment
    
              -  No other active malignancy
    
              -  Age ≥ 18 years
    
              -  Performance Status Eastern Cooperative Oncology Group (ECOG) 0-1 (Appendix 21.5).
    
              -  Other study-specific criteria:
    
              -  Men of child-bearing potential must not donate sperm while on this study and for 90
                 days after their last study treatment.
    
            NOTE: Acceptable forms of birth control are listed below:
    
              -  One Barrier method (cervical cap with spermicide plus male condom; diaphragm with
                 spermicide plus male condom) PLUS
    
              -  Hormonal method (oral contraceptives, implants, or injections) or an intrauterine
                 device (e.g., Copper-T).
    
            Exclusion Criteria:
    
              -  Current or anticipated use of other investigational agents while participating in this
                 study.
    
              -  Psychiatric illness/social situations that would limit compliance with study
                 requirements
    
              -  Prior pelvic radiation therapy
    
              -  Prior prostatectomy
    
              -  Inflammatory bowel disease or connective tissue disease requiring medical management
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Toxicity Rates
    Time Frame:up to 5 year post radiation
    Safety Issue:
    Description:Patient reported urinary function, as defined by the EPIC-26 GU domain patient reported outcome for prostate cancer patients

    Secondary Outcome Measures

    Measure:Biochemical Control Rate
    Time Frame:1 month post-Radiation Therapy (RT), every 3 months- post RT for the first year and then every 6 months post RT for the next 4 years
    Safety Issue:
    Description:Biochemical freedom from progression as defined by ASTRO Phoenix criteria at 3 years
    Measure:Radiation Therapy Oncology Group (RTOG) Late Toxicity Rate
    Time Frame:3 year
    Safety Issue:
    Description:Rate of Grade 3+ gastrointestinal (GI) or genitourinary (GU) late toxicity at 3 years as defined by RTOG late toxicity scored on a 1 to 4 scale with a higher value representing a worse outcome.
    Measure:RTOG Acute Toxicity Rate
    Time Frame:90 days
    Safety Issue:
    Description:Rate of Grade 2+ GI or GU acute toxicity within 90 days of treatment as defined by RTOG acute toxicity scored on a 1 to 4 scale with a higher value representing a worse outcome.
    Measure:Oxidative stress as a predictor of toxicity
    Time Frame:1 month post-RT, every 3 months- post RT for the first year and then every 6 months post RT for the next 4 years
    Safety Issue:
    Description:exploring the oxidative stress markers of the patient to use as a predictor of acute and late toxicty
    Measure:Financial Toxicity Measurement
    Time Frame:3 months, 6 months, and 12 month visits only
    Safety Issue:
    Description:Determined by evaluation of patient completion of questionnaire

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:University of Kansas Medical Center

    Trial Keywords

    • Radiation Therapy
    • ultra-short Radiation
    • SBRT
    • prostate
    • quality of life
    • financial toxicity

    Last Updated

    April 16, 2019