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Trial record 1 of 1 for:    gu013
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Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer

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ClinicalTrials.gov Identifier: NCT05946213
Recruitment Status : Recruiting
First Posted : July 14, 2023
Last Update Posted : February 7, 2024
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology

Study Description
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Brief Summary:
This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.

Condition or disease Intervention/treatment Phase
Stage III Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Radiation: External Beam Radiation Therapy Radiation: Stereotactic Body Radiation Therapy Phase 3

Detailed Description:

PRIMARY OBJECTIVE:

I. To compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (stereotactic body radiation therapy [SBRT]) to those randomized to moderate hypofractionation and conventional fractionation.

SECONDARY OBJECTIVES:

I. To compare physician-reported toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5 between treatment arms.

II. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported urinary function (assessed by Expanded Prostate Cancer Index Composite [EPIC]-26 urinary domains).

III. To determine if ultrahypofractionation is non-inferior to moderate hypofractionation and conventional fractionation with respect to patient-reported bowel function (assessed by EPIC-26 bowel domain).

IV. To compare patient-reported fatigue (assessed by Patient Reported Outcomes Measurement Information System [PROMIS]-Fatigue) between treatment arms.

V. To compare patient-reported treatment burden (assessed by COmprehensive Score for financial Toxicity [COST]) between treatment arms.

VI. To compare failure-free survival between treatment arms. VII. To compare metastasis-free survival based on molecular imaging between treatment arms.

VIII. To compare overall survival between treatment arms.

EXPLORATORY OBJECTIVES:

I. To compare patient-reported sexual function (assessed by EPIC-26 sexual domain) between treatment arms.

II. To compare patient-reported quality of life (assessed by European Quality of Life Five Dimension Five Level Scale Questionnaire [EQ-5D-5L]) between treatment arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo SBRT for a total of 5 treatments over 2 weeks.

ARM II: Patients undergo external beam radiation treatment (EBRT) for 20-45 treatments over 4 to 9 weeks.

Patients are followed up every 6 months for 5 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Phase III 'High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer
Actual Study Start Date : November 13, 2023
Estimated Primary Completion Date : March 31, 2036
Estimated Study Completion Date : March 31, 2041

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (SBRT)
Patients undergo SBRT for a total of 5 treatments over 2 weeks.
 Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy
Active Comparator: Arm II (EBRT)
Patients undergo EBRT for 20 to 45 treatments over 4 to 9 weeks.
 Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiation
  • External Beam Radiotherapy
  • External Beam Radiotherapy (conventional)
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation, External Beam
  • Teleradiotherapy
  • Teletherapy
  • Teletherapy Radiation


Outcome Measures
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Primary Outcome Measures :
  1. Metastasis-Free Survival (MFS) [ Time Frame: From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years ]
    Based on conventional imaging. MFS will be estimated using the Kaplan-Meier method (Kaplan 1958). A confidence interval approach will be used adjusting for stratification factors. If the one sided 95% upper confidence limit of HR < 1.35, then the null hypothesis of inferiority will be rejected. If the 95% upper confidence limit excludes HR=1.35, then the null hypothesis of inferiority will be rejected. Cox proportional hazards models will be used to obtain unadjusted and adjusted HRs and 95% confidence intervals for the treatment effects.


Secondary Outcome Measures :
  1. Failure-Free Survival [ Time Frame: From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years ]
    Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test. Cox proportional hazards models will be used to determine hazard ratios and to assess the effects of stratification factors and other covariates of interest, such as age, race, antiandrogen therapy (ADT) adherence, T stage, Gleason score, and performance status on outcomes.

  2. Overall Survival [ Time Frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 15 years ]
    Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test. Cox proportional hazards models will be used to determine hazard ratios and to assess the effects of stratification factors and other covariates of interest, such as age, race, ADT adherence, T stage, Gleason score, and performance status on outcomes.

  3. MFS [ Time Frame: From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years ]
    Based on molecular imaging. Will be estimated using the Kaplan-Meier method and treatment arms compared using the stratified log-rank test. Cox proportional hazards models will be used to determine hazard ratios and to assess the effects of stratification factors and other covariates of interest, such as age, race, ADT adherence, T stage, Gleason score, and performance status on outcomes.

  4. Incidence of Adverse Events (AEs) [ Time Frame: Up to 15 years ]
    AEs will be graded using National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5. Counts of all AEs by grade will be provided by treatment arm.

  5. Urinary Incontinence domain of the Expanded Prostate Cancer Index Composite (EPIC-26) [ Time Frame: Up to 5 years ]
    Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life.

  6. Urinary Irritative/Obstructive domain of the Expanded Prostate Cancer Index Composite (EPIC-26) [ Time Frame: Up to 5 years ]
    Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life.

  7. Bowel domain of the Expanded Prostate Cancer Index Composite (EPIC-26) [ Time Frame: Up to 5 years ]
    Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life.

  8. Fatigue [ Time Frame: Up to 5 years ]
    Measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue. Raw scores range from 7 to 35 and are standardized. A higher score indicates more fatigue.

  9. Cost [ Time Frame: Up to 1 year ]
    Measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-COST.


Other Outcome Measures:
  1. Patient-reported outcomes [ Time Frame: Up to 5 years ]
    The EPIC-26 sexual domain will be assessed as an exploratory endpoint. Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life.


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:

  • Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer

  • High-risk disease defined as having at least one or more of the following:

    • cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.]) Note: cT4 by imaging or on digital rectal exam is not allowed
    • The patient's prostate specific antigen (PSA) > 20 ng/mL prior to starting ADT Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible. The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors
    • Gleason Score of 8-10
    • Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm
  • Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or computed tomography (CT) scan
  • No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute
  • Age >= 18
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • No prior radical prostatectomy
  • Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone [LHRH] agonist and oral anti-androgen) is =< 185 days prior to registration
  • Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy
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): NCT05946213


Locations
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Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Karen E Hoffman NRG Oncology
More Information
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Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT05946213    
Other Study ID Numbers: NRG-GU013
NCI-2023-04142 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-GU013 ( Other Identifier: NRG Oncology )
NRG-GU013 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: February 7, 2024
Last Verified: February 2024

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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
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases