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Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hypofractionated Radiation Therapy
Quality-of-Life Assessment
Questionnaire Administration
Radiation Therapy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage I Prostate Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • M D Anderson Cancer CenterRecruiting
  • MD Anderson League CityRecruiting
  • MD Anderson in Sugar LandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (conventional radiation therapy)

Arm II (hypofractionated radiation therapy)

Arm Description

Patients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery.

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

Outcomes

Primary Outcome Measures

Incidence of >= grade 2 gastrointestinal (GI) or genitourinary (GU) toxicity
Will be denoted as Tc and Te for conventional and hypo-fractionated arm respectively.

Secondary Outcome Measures

Local control
Loco-regional control
Distant metastases
Biochemical progression-free survival
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.
Prostate-cancer specific survival (PCSS)
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.
Time to salvage therapy
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.
Biochemical failure (FFBF)
Time to progression (TTP)
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.
Patient reported quality of life outcomes
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.
Patient reported GU symptoms
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.
Patient reported GI symptoms
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.
Health economics
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.

Full Information

First Posted
January 25, 2019
Last Updated
October 5, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03987386
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (conventional radiation therapy)
Arm Type
Active Comparator
Arm Description
Patients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery.
Arm Title
Arm II (hypofractionated radiation therapy)
Arm Type
Experimental
Arm Description
Patients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated Radiation Therapy
Other Intervention Name(s)
Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated
Intervention Description
Undergo hypofractionated radiation therapy
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo conventional radiation therapy
Primary Outcome Measure Information:
Title
Incidence of >= grade 2 gastrointestinal (GI) or genitourinary (GU) toxicity
Description
Will be denoted as Tc and Te for conventional and hypo-fractionated arm respectively.
Time Frame
At 2 years
Secondary Outcome Measure Information:
Title
Local control
Time Frame
Up to 5 years
Title
Loco-regional control
Time Frame
Up to 5 years
Title
Distant metastases
Time Frame
Up to 5 years
Title
Biochemical progression-free survival
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.
Time Frame
Up to 5 years
Title
Prostate-cancer specific survival (PCSS)
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.
Time Frame
Up to 5 years
Title
Time to salvage therapy
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.
Time Frame
Up to 5 years
Title
Biochemical failure (FFBF)
Time Frame
Up to 5 years
Title
Time to progression (TTP)
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.
Time Frame
Up to 5 years
Title
Patient reported quality of life outcomes
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, 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.
Time Frame
Up to 5 years
Title
Patient reported GU symptoms
Description
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.
Time Frame
At end of radiation therapy (RT), 6, 12, 24 and up to 60 months from the end of RT
Title
Patient reported GI symptoms
Description
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.
Time Frame
At end of RT, 6, 12, 24, and up to 60 months from the end of RT
Title
Health economics
Description
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.
Time Frame
Up to 5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quynh-Nhu Nguyen
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quynh-Nhu Nguyen, MD
Phone
713-563-2300
Email
qnnguyen@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Quynh-Nhu Nguyen, MD
Facility Name
MD Anderson League City
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren L. Mayo, MD
Phone
832-691-8745
Email
LLMayo@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Lauren L. Mayo, MD
Facility Name
MD Anderson in Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shalin J. Shah, MD
Phone
281-566-1802
Email
sjshah@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Shalin J. Shah, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

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