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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 : June 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
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 Radiation: Hypofractionated Radiation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Radiation Therapy Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/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 Name: 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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




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, 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 EPIC-26.

  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 EPIC-26.

  12. Health economics [ Time Frame: 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.



Information from the National Library of Medicine

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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:

  • 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)

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


Contacts
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Contact: Quynh-Nhu Nguyen 713-563-2300 qnnguyen@mdanderson.org

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      
Principal Investigator: Quynh-Nhu Nguyen, 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

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03987386     History of Changes
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 )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
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
Genital Diseases, Male
Prostatic Diseases