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Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03987386
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : October 3, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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 beams 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.

Condition or disease Intervention/treatment Phase
Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Radiation: Hypofractionated Radiation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Radiation Therapy Phase 3

Detailed Description:

PRIMARY OBJECTIVE:

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.

Ia. 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.

II. 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, Short Form [SF]-12, EuroQol 5 dimensional [EQ-5D]) and use of erectile dysfunction medications/devices.

III. To compare patient reported GU symptoms using the Common Terminology Criteria for Adverse Events (CTCAE) version 5 (specifically GU symptoms) and quality of life reports with EPIC-26, SF-12, EQ-5D survey at end of radiation therapy (RT), 6, 12, 24 and up to 60 months from the end of radiation therapy.

IV. To compare patient reported GI symptoms using CTCAE version 5 (specifically GI symptoms) and quality of life reports with the EPIC-26 SF-12, EQ-5D survey at end of RT, 6, 12, 24, and up to 60 months from the end of radiation therapy.

V. To report health economics with cost and time based driven activity (TDABC) 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 7 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 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
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm I (conventional radiation therapy)
Patients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery.
 Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Radiation: Radiation Therapy
Undergo conventional radiation therapy
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • 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
  • Hypofractionated Radiotherapy
  • hypofractionation
  • Radiation, Hypofractionated

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of >= grade 2 gastrointestinal (GI) or genitourinary (GU) toxicity [ Time Frame: At 2 years ]
    Will be denoted as Tc and Te for conventional and hypo-fractionated arm respectively.


Secondary Outcome Measures :
  1. Local control [ Time Frame: Up to 5 years ]
  2. Loco-regional control [ Time Frame: Up to 5 years ]
  3. Distant metastases [ Time Frame: Up to 5 years ]
  4. Biochemical progression-free survival [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Up to 5 years ]
  8. Time to progression (TTP) [ Time Frame: 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 [ Time Frame: 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, Short Form [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 [ Time Frame: At end of radiation therapy (RT), 6, 12, 24 and up to 60 months from the end of RT ]
    Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5. Will be compared to quality of life reports with EPIC-26, SF-12, EQ-5D survey. Quality of life (QOL) data 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. The generalized estimating equations (GEE) model will be fit to assess the change of GU or GI symptoms over time as well as treatment effect.

  11. Patient reported GI symptoms [ Time Frame: At end of RT, 6, 12, 24, and up to 60 months from the end of RT ]
    Will be assessed by CTCAE version 5. Will be compared to quality of life reports with EPIC-26, SF-12, EQ-5D survey. QOL data 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. The GEE model will be fit to assess the change of GU or GI symptoms over time as well as treatment effect.

  12. Health economics [ Time Frame: Up to 5 years ]
    Will report health economics with cost and time based driven activity (TDABC) 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men age 18 or older
  • 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 T2-T3M0 stage. Patients can have 5 or less metastatic pelvic lymph nodes confirmed by pathology
  • For patients radiated in the post-operative salvage setting: pathology can demonstrate any of the following features but not required, positive margin, extracapsular extension, or seminal vesicle involvement with detectable prostate-specific antigen (PSA) of >= 0.1. PSA >= 0.1 after radical prostatectomy: most recent PSA value within 12 months of registration and prior to initiating any androgen deprivation therapy (ADT)
  • Patient diagnosed with Gleason score of 6-10
  • 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 12 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:

  • 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 or uncontrolled diabetes
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987386


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Quynh-Nhu Nguyen, MD    713-563-2300    qnnguyen@mdanderson.org   
Principal Investigator: Quynh-Nhu Nguyen, MD         
MD Anderson League City Recruiting
League City, Texas, United States, 77573
Contact: Lauren L. Mayo, MD    832-691-8745    LLMayo@mdanderson.org   
Principal Investigator: Lauren L. Mayo, MD         
MD Anderson in Sugar Land Recruiting
Sugar Land, Texas, United States, 77478
Contact: Shalin J. Shah, MD    281-566-1802    sjshah@mdanderson.org   
Principal Investigator: Shalin J. Shah, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Quynh-Nhu Nguyen M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03987386    
Other Study ID Numbers: 2018-0703
NCI-2018-03367 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0703 ( Other Identifier: M D Anderson Cancer Center )
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: October 3, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases