Clinical Trials /

Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer

NCT01794403

Description:

Accelerated Hypofractionation Radiotherapy for prostate cancer of 36.25 Gy delivered in 5 fractions will not be inferior to the standard treatment of 70.2 Gy given in 26 fractions with respect to two-year failure defined as a positive biopsy two years post treatment completion or earlier evidence of biochemical or clinical failure.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer
  • Official Title: A Randomized Study of Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 20110491
  • NCT ID: NCT01794403

Conditions

  • Prostate Cancer

Purpose

Accelerated Hypofractionation Radiotherapy for prostate cancer of 36.25 Gy delivered in 5 fractions will not be inferior to the standard treatment of 70.2 Gy given in 26 fractions with respect to two-year failure defined as a positive biopsy two years post treatment completion or earlier evidence of biochemical or clinical failure.

Trial Arms

NameTypeDescriptionInterventions
Extended Hypofractionation (EHRT)Active ComparatorExtended Hypofractionation Radiotherapy: A total dose of 70.2 Gy, 26 fractions, 2.7 Gy to the Planning Target Volume (PTV). Expanded Prostate Cancer Index Composite SF-12 (EPIC SF-12) quality of life questionnaire; International Prostate Symptom Score (IPSS) quality of life questionnaire; Memorial Anxiety Scale for Prostate Cancer patients (MAX-PC) quality of life questionnaire; OPTIONAL: Ultrasound-guided biopsy, blood and urine samples for correlative studies.
    Accelerated Hypofractionation (AHRT)ExperimentalAccelerated Hypofractionation Radiotherapy: A total dose of 36.25 Gy, 5 fractions, 7.25 Gy each to the Planning Target Volume (PTV); Expanded Prostate Cancer Index Composite SF-12 (EPIC SF-12) quality of life questionnaire; International Prostate Symptom Score (IPSS) quality of life questionnaire; Memorial Anxiety Scale for Prostate Cancer patients (MAX-PC) quality of life questionnaire; OPTIONAL: Ultrasound-guided biopsy, blood and urine samples for correlative studies.

      Eligibility Criteria

              Inclusion Criteria:
      
                1. Histologically proven prostate adenocarcinoma.
      
                     -  Gleason score 2-7 (reviewed by reference lab at UM).
      
                     -  Biopsy within one year of date of enrollment.
      
                2. Clinical stage ≤ T2 based on DRE and/or ≤ T3a based on MRI (if done); N0-Nx; M0-Mx
                   (AJCC 7th Edition)
      
                     -  T-stage and N-stage determined by physical exam and available imaging studies
                        (CT, and/or MRI of the pelvis; see section 4.5). For MRI, questionable
                        extracapsular extension is permitted. To distinguish blood from tumor the ideal
                        study would be to acquire T2, T1 noncontrast and T1 dynamic contrast enhanced
                        sequence, although this is not required. A small amount of extracapsular
                        extension is permitted, as long as it can be included in the clinical target
                        volume (CTV) and the constraints are met.
      
                     -  M-stage determined by physical exam, CT or MRI. Bone scan not required unless
                        clinical findings suggest possible osseous metastases.
      
                3. Prostate-Specific Antigen (PSA) ≤ 15 ng/ml, obtained no greater than 3 months prior
                   to enrollment.
      
                4. Patients belonging in one of the following risk groups:
      
                     -  Low:
      
                          -  Clinical stage* T1-T2; Gleason ≤ 6, PSA ≤ 10 & <50% biopsy cores positive.
      
                     -  Intermediate:
      
                          -  Clinical stage T2b-T2c; Gleason ≤ 6, PSA ≤ 10 & <50% biopsy cores positive.
      
                          -  Clinical stage T1-T2; Gleason ≤ 6, PSA ≤ 10 & ≥50% biopsy cores positive.
      
                          -  Clinical stage T1-T2; Gleason = 7, PSA ≤ 10 & <50% biopsy cores positive or
                             T1-T2; Gleason ≤ 6 & PSA >10 and ≤15 & <50% biopsy cores positive.
      
                          -  MRI stage T3a with evidence of extraprostatic extension is allowed.
      
                          -  Clinical stage is based on digital rectal exam (DRE). Seminal vesicle
                             invasion on MRI is not eligible. T1a should be permitted if subsequent
                             peripheral zone biopsies show tumor.
      
                5. Prostate volume: ≤ 80 cc.
      
                     -  Determined using: volume = π/6 x length x height x width.
      
                     -  Measured from CT or MRI ≤90 days prior to enrollment.
      
                6. Zubrod performance status 0-1.
      
                7. No prior total prostatectomy or cryotherapy of the prostate.
      
                     -  Prior suprapubic prostatectomy, transurethral resection and laser ablation are
                        permitted.
      
                8. No prior radiotherapy to the prostate or lower pelvis.
      
                9. No implanted hardware or other material that would prohibit appropriate treatment
                   planning or treatment delivery, in the investigator's opinion.
      
               10. No chemotherapy for a malignancy in the last 5 years.
      
               11. No history of an invasive malignancy (other than this prostate cancer, or
                   nonmetastatic basal or squamous skin cancers) in the last 5 years.
      
               12. No more than 4 months of androgen deprivation therapy (ADT) prior to enrollment. If
                   given, prior to enrollment, ADT cannot be continued during radiation or plan to
                   delivered after the completion of radiation therapy.
      
               13. Patient must be able to have gold fiducial markers placed in the prostate (if on
                   anticoagulants, must be cleared by a primary care physician or cardiologist), or if
                   patient already has fiducial marker placed, they must be in accordance with the
                   protocol specifications (Section 4.2.2)
      
               14. Ability to understand and the willingness to sign a written informed consent
                   document.
      
               15. Willingness to fill out quality of life/psychosocial forms.
      
               16. Age >= 35 and =< 85 years.
      
               17. IPSS (AUA) score ≤12
      
              Exclusion Criteria:
      
                1. Does not have a diagnosis of prostate adenocarcinoma.
      
                2. Patient has clinical T3a or any evidence of T3b disease.
      
                3. Patient has stage N1 or M1 disease.
      
                4. Patients has a PSA of greater than 15 ng/ml.
      
                5. Patient does not meet any of the risk groups outlined in section 3.1.4.
      
                6. Prostate volume greater than 80 cc.
      
                7. Zubrod performance status 2 or greater.
      
                8. Prior total prostatectomy.
      
                9. Prior radiation therapy to the prostate or lower pelvis.
      
               10. Implanted hardware which limits treatment planning or delivery (determined by the
                   investigator).
      
               11. Chemotherapy within the past 5 years.
      
               12. Diagnosis of an invasive malignancy within 5 years (other than current prostate
                   cancer or non-metastatic basal or squamous skin cancers).
      
               13. The use of more than 4 months of androgen deprivation therapy (ADT) prior to
                   enrollment, or plans for ADT to be continued during radiation to be delivered after
                   the completion of radiation therapy.
      
               14. Inability to have gold fiducial markers placed in the prostate, or fiducial markers
                   already placed that are not in accordance with the protocol (Section 4.2.2)
      
               15. Unwilling or inability to give informed consent.
      
               16. Not willing to fill out quality of life/psychosocial questionnaires.
      
               17. IPSS score > to 12.
      
               18. Age < 35 and > 85 years.
            
      Maximum Eligible Age:85 Years
      Minimum Eligible Age:35 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Compare the two-year failure rates (biochemical or clinical failure, or positive biopsy) between the treatment arms (AHRT and EHRT) using a noninferiority margin of 12%.
      Time Frame:2 years
      Safety Issue:
      Description:

      Secondary Outcome Measures

      Measure:Compare acute toxicity rates of AHRT and EHRT.
      Time Frame:2 years
      Safety Issue:
      Description:
      Measure:Compare Efficacy of AHRT with EHRT
      Time Frame:2 years
      Safety Issue:
      Description:Compare the efficacy of AHRT with EHRT for the treatment of low and early intermediate risk prostate cancer, where efficacy is defined by biochemical failure using Phoenix (Nadir+2) definition or clinical failure.
      Measure:Compare AHRT and EHRT overall survival
      Time Frame:2 years
      Safety Issue:
      Description:Compare AHRT and EHRT with respect to prostate cancer mortality and overall survival.
      Measure:Compare AHRT and EHRT quality of life
      Time Frame:2 years
      Safety Issue:
      Description:Compare AHRT and EHRT with respect to quality of life (QOL), including erectile dysfunction rates, in generic and organ-specific domains.
      Measure:Rates of ASTRO-defined biochemical failure.
      Time Frame:2 years
      Safety Issue:
      Description:
      Measure:Relationship of biomarkers from pretreatment diagnostic tissue and blood to the efficacy endpoints, toxicity and QOL.
      Time Frame:2 years
      Safety Issue:
      Description:Examine the relationship of biomarkers from pretreatment diagnostic tissue and blood to the efficacy endpoints, toxicity and QOL.
      Measure:Rates of late-occurring grade 2 or greater GI/GU toxicity
      Time Frame:2 years
      Safety Issue:
      Description:To compare the rates of late-occurring grade 2 or greater gastrointestinal (GI) or genitourinary (GU) toxicity.
      Measure:Effectiveness of AHRT and EHRT
      Time Frame:2 years
      Safety Issue:
      Description:Evaluate the comparative effectiveness of each treatment regimen.
      Measure:Cost utility of AHRT and EHRT
      Time Frame:2 years
      Safety Issue:
      Description:Examine the cost utility of each treatment regimen.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:University of Miami

      Trial Keywords

      • Prostate Cancer
      • Prostate
      • Radiation Therapy
      • Hypofractionation Radiotherapy
      • Extended Hypofractionation Radiotherapy
      • Accelerated Hypofractionation Radiotherapy
      • AHRT
      • EHRT

      Last Updated

      March 14, 2017