Clinical Trials /

Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

NCT03987386

Description:

This phase III trial studies how well hypofractionated radiation therapy works compared to the conventional one in treating patients with prostate cancer. Radiation therapy uses high energy beam to kill tumor cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer
  • Official Title: Post Operative External Beam Radiotherapy for Prostate Cancer: Randomized Trial Comparing Standard vs. Hypofractionated Radiation Therapy. (PORT-HYFX)

Clinical Trial IDs

  • ORG STUDY ID: 2018-0703
  • SECONDARY ID: NCI-2018-03367
  • SECONDARY ID: 2018-0703
  • SECONDARY ID: P30CA016672
  • NCT ID: NCT03987386

Conditions

  • Stage I Prostate Cancer AJCC v8
  • Stage II Prostate Cancer AJCC v8
  • Stage IIA Prostate Cancer AJCC v8
  • Stage IIB Prostate Cancer AJCC v8
  • Stage IIC Prostate Cancer AJCC v8
  • Stage III Prostate Cancer AJCC v8
  • Stage IIIA Prostate Cancer AJCC v8
  • Stage IIIB Prostate Cancer AJCC v8
  • Stage IIIC Prostate Cancer AJCC v8

Purpose

This phase III trial studies how well hypofractionated radiation therapy works compared to the conventional one in treating patients with prostate cancer. Radiation therapy uses high energy beam to kill tumor cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To assess the gastrointestinal (GI) and genitourinary (GU) toxicities in patients treated
      with hypo-fractionated postoperative radiotherapy relative to the conventional postoperative
      radiotherapy.

      SECONDARY OBJECTIVES:

      I. To report patient outcome to include local control, loco-regional control, distant
      metastases, biochemical progression-free survival, prostate-cancer specific survival (PCSS),
      time to salvage therapy.

      II. To compare freedom from biochemical failure (FFBF) and time to progression (TTP) with
      definition of post prostatectomy nadir + 2 ng/mL in both treatment arms.

      III. To evaluate patient reported quality of life outcomes with hypo-fractionated compared to
      standard fractionated postoperative radiotherapy using validated surveys (Expanded Prostate
      Cancer Index Composite [EPIC]-26, SF-12) and use of erectile dysfunction medications/devices.

      IV. To compare patient reported GU symptoms using the EPIC-26 survey at end of radiation
      therapy (RT), 6, 12, 24 and up to 60 months from the end of radiation therapy.

      V. To compare patient reported GI symptoms using the EPIC-26 survey at end of RT, 6, 12, 24,
      and up to 60 months from the end of radiation therapy.

      VI. To report health economics in delivering shorter hypofractionated courses of radiotherapy
      compared to standard course (indirect and direct cost).

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients undergo conventional radiation therapy daily over 6.5 weeks after standard of
      care surgery.

      ARM II: Patients undergo hypofractionated radiation therapy over 4.5 weeks after standard of
      care surgery.

      After completion of study treatment, patients are followed up at 3-6 months, and then every
      6-12 months for up to 5 years.
    

Trial Arms

NameTypeDescriptionInterventions
Arm I (conventional radiation therapy)Active ComparatorPatients undergo conventional radiation therapy daily over 6.5 weeks after standard of care surgery.
    Arm II (hypofractionated radiation therapy)ExperimentalPatients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery.

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Patient has diagnosis of pathologically confirmed prostate cancer, treated with
                   radical prostatectomy. Any type of radical prostatectomy will be permitted, including
                   retropubic, perineal, laparoscopic, or robotically assisted
      
                -  Patient has pathologic T2N0M0 or T3N0M0 stage
      
                -  Patient diagnosed with Gleason score of 6-10
      
                -  For patients radiated in the adjuvant setting: pathology demonstrates positive margin,
                   extracapsular extension, or seminal vesicle involvement without detectable prostate
                   specific antigen (PSA) (PSA of 0.0)
      
                -  For patients radiated in the salvage setting: pathology demonstrates positive margin,
                   extracapsular extension, seminal vesicle involvement with detectable PSA of > 0.1
      
                -  Eastern Cooperative Oncology Group (ECOG) performance 0-2
      
                -  Patients may receive 6 months and up to 24 months of androgen deprivation therapy.
                   Patients may have received androgen deprivation therapy up to 6 months prior to
                   postoperative radiotherapy
      
                -  If the patient has a prior history of any cancer other than prostate cancer, he must
                   have completed treatment within 1 year of study registration and the patient must have
                   no evidence of disease of this prior non-prostate cancer
      
              Exclusion Criteria:
      
                -  Any evidence of nodal positivity beyond pathologic stage pN0
      
                -  Prior radiation therapy to prostate/seminal vesicle fossa or postoperative region
      
                -  Neoadjuvant chemotherapy before or after prostatectomy
      
                -  History of lupus, scleroderma, or calcinosis, Raynaud's phenomenon, esophageal
                   dysmotility, sclerodactyly, and telangiectasia (CREST) syndrome
      
                -  History of severe active co-morbidity
      
                -  Unstable angina and/or congestive heart failure requiring hospitalization within the
                   last 6 months
      
                -  Transmural myocardial infarction within the last 6 months
      
                -  Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic
                   disease
      
                -  End-stage renal disease (i.e., on dialysis or dialysis has been recommended)
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Incidence of >= grade 2 gastrointestinal (GI) or genitourinary (GU) toxicity
      Time Frame:At 2 years
      Safety Issue:
      Description:Will be denoted as Tc and Te for conventional and hypo-fractionated arm respectively.

      Secondary Outcome Measures

      Measure:Local control
      Time Frame:Up to 5 years
      Safety Issue:
      Description:
      Measure:Loco-regional control
      Time Frame:Up to 5 years
      Safety Issue:
      Description:
      Measure:Distant metastases
      Time Frame:Up to 5 years
      Safety Issue:
      Description:
      Measure:Biochemical progression-free survival
      Time Frame:Up to 5 years
      Safety Issue:
      Description:Will be analyzed using the Kaplan-Meier method. Log-rank test will be used to assess the differences in time-to-event outcomes between the two groups. Cox proportional hazards model will be fit to compare the two arms while accounting for other patient characteristics.
      Measure:Prostate-cancer specific survival (PCSS)
      Time Frame:Up to 5 years
      Safety Issue:
      Description:Will be analyzed using the Kaplan-Meier method. Log-rank test will be used to assess the differences in time-to-event outcomes between the two groups. Cox proportional hazards model will be fit to compare the two arms while accounting for other patient characteristics.
      Measure:Time to salvage therapy
      Time Frame:Up to 5 years
      Safety Issue:
      Description:Will be analyzed using the Kaplan-Meier method. Log-rank test will be used to assess the differences in time-to-event outcomes between the two groups. Cox proportional hazards model will be fit to compare the two arms while accounting for other patient characteristics.
      Measure:Biochemical failure (FFBF)
      Time Frame:Up to 5 years
      Safety Issue:
      Description:
      Measure:Time to progression (TTP)
      Time Frame:Up to 5 years
      Safety Issue:
      Description:Will be defined as post prostatectomy nadir + 2 ng/mL in both treatment arms. Will be analyzed using the Kaplan-Meier method. Log-rank test will be used to assess the differences in time-to-event outcomes between the two groups. Cox proportional hazards model will be fit to compare the two arms while accounting for other patient characteristics.
      Measure:Patient reported quality of life outcomes
      Time Frame:Up to 5 years
      Safety Issue:
      Description:Will evaluate patient reported quality of life outcomes with hypo-fractionated compared to standard fractionated postoperative radiotherapy using validated surveys (Expanded Prostate Cancer Index Composite [EPIC]-26, SF-12) and use of erectile dysfunction medications/devices. Will be summarized using descriptive statistics by treatment arm and will be compared using two sample t-test or Wilcoxon rank-sum test as appropriate.
      Measure:Patient reported GU symptoms
      Time Frame:At end of radiation therapy (RT), 6, 12, 24 and up to 60 months from the end of RT
      Safety Issue:
      Description:Will be assessed by EPIC-26.
      Measure:Patient reported GI symptoms
      Time Frame:At end of RT, 6, 12, 24, and up to 60 months from the end of RT
      Safety Issue:
      Description:Will be assessed by EPIC-26.
      Measure:Health economics
      Time Frame:Up to 5 years
      Safety Issue:
      Description:Will report health economics in delivering shorter hypofractionated courses of radiotherapy compared to standard course (indirect and direct cost). Will be summarized using descriptive statistics by treatment arm and will be compared using two sample t-test or Wilcoxon rank-sum test as appropriate.

      Details

      Phase:Phase 3
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:M.D. Anderson Cancer Center

      Last Updated

      June 11, 2019