- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03987386
Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer
Post Operative External Beam Radiotherapy for Prostate Cancer: Randomized Trial Comparing Standard vs. Hypofractionated Radiation Therapy (PORT-HYFX)
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Quynh-Nhu Nguyen, MD
- Phone Number: 713-563-2300
- Email: qnnguyen@mdanderson.org
-
Principal Investigator:
- Quynh-Nhu Nguyen, MD
-
League City, Texas, United States, 77573
- Recruiting
- MD Anderson League City
-
Contact:
- Lauren L. Mayo, MD
- Phone Number: 832-691-8745
- Email: LLMayo@mdanderson.org
-
Principal Investigator:
- Lauren L. Mayo, MD
-
Sugar Land, Texas, United States, 77478
- Recruiting
- MD Anderson in Sugar Land
-
Contact:
- Shalin J. Shah, MD
- Phone Number: 281-566-1802
- Email: sjshah@mdanderson.org
-
Principal Investigator:
- Shalin J. Shah, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm I (conventional radiation therapy)
Patients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery.
|
Ancillary studies
Other Names:
Ancillary studies
Undergo conventional radiation therapy
Other Names:
|
Experimental: Arm II (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery.
|
Ancillary studies
Other Names:
Ancillary studies
Undergo hypofractionated radiation therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local control
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Distant metastases
Time Frame: Up to 5 years
|
Up to 5 years
|
|
Loco-regional control
Time Frame: Up to 5 years
|
Up to 5 years
|
|
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.
|
Up to 5 years
|
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.
|
Up to 5 years
|
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.
|
Up to 5 years
|
Biochemical failure (FFBF)
Time Frame: Up to 5 years
|
Up to 5 years
|
|
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.
|
Up to 5 years
|
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.
|
Up to 5 years
|
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.
|
At end of radiation therapy (RT), 6, 12, 24 and up to 60 months from the end of RT
|
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.
|
At end of RT, 6, 12, 24, and up to 60 months from the end of RT
|
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.
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Quynh-Nhu Nguyen, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0703 (Other Identifier: M D Anderson Cancer Center)
- NCI-2018-03367 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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