Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03987386
Collaborator
National Cancer Institute (NCI) (NIH)
176
Enrollment
1
Location
2
Arms
65.1
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:
  1. 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:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
176 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Post Operative External Beam Radiotherapy for Prostate Cancer: Randomized Trial Comparing Standard vs. Hypofractionated Radiation Therapy. (PORT-HYFX)
Actual Study Start Date :
May 30, 2019
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Arm I (conventional radiation therapy)

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

Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Radiation: Radiation Therapy
    Undergo conventional radiation therapy
    Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • RADIOTHERAPY
  • RT
  • Therapy, Radiation
  • Experimental: Arm II (hypofractionated radiation therapy)

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

    Radiation: Hypofractionated Radiation Therapy
    Undergo hypofractionated radiation therapy
    Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of >= grade 2 gastrointestinal (GI) or genitourinary (GU) toxicity [At 2 years]

      Will be denoted as Tc and Te for conventional and hypo-fractionated arm respectively.

    Secondary Outcome Measures

    1. Local control [Up to 5 years]

    2. Loco-regional control [Up to 5 years]

    3. Distant metastases [Up to 5 years]

    4. Biochemical progression-free survival [Up to 5 years]

      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.

    5. Prostate-cancer specific survival (PCSS) [Up to 5 years]

      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.

    6. Time to salvage therapy [Up to 5 years]

      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.

    7. Biochemical failure (FFBF) [Up to 5 years]

    8. Time to progression (TTP) [Up to 5 years]

      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.

    9. Patient reported quality of life outcomes [Up to 5 years]

      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.

    10. Patient reported GU symptoms [At end of radiation therapy (RT), 6, 12, 24 and up to 60 months from the end of RT]

      Will be assessed by EPIC-26.

    11. Patient reported GI symptoms [At end of RT, 6, 12, 24, and up to 60 months from the end of RT]

      Will be assessed by EPIC-26.

    12. Health economics [Up to 5 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1M D Anderson Cancer CenterHoustonTexasUnited States77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Quynh-Nhu Nguyen, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03987386
    Other Study ID Numbers:
    • 2018-0703
    • NCI-2018-03367
    • 2018-0703
    • P30CA016672
    First Posted:
    Jun 17, 2019
    Last Update Posted:
    Mar 29, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2021