Stage IVA Prostate Cancer AJCC v8 Clinical Trial
Official title:
The Phase III 'High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer
Verified date | February 2024 |
Source | NRG Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 1209 |
Est. completion date | March 31, 2041 |
Est. primary completion date | March 31, 2036 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | McFarland Clinic - Ames | Ames | Iowa |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Langlade Hospital and Cancer Center | Antigo | Wisconsin |
United States | Kaiser Permanente-Deer Valley Medical Center | Antioch | California |
United States | Saint Joseph Mercy Brighton | Brighton | Michigan |
United States | Aultman Health Foundation | Canton | Ohio |
United States | Saint Joseph Mercy Canton | Canton | Michigan |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania |
United States | Saint Joseph Mercy Chelsea | Chelsea | Michigan |
United States | Northwestern University | Chicago | Illinois |
United States | Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois |
United States | Kaiser Permanente Dublin | Dublin | California |
United States | Saint Luke's Hospital of Duluth | Duluth | Minnesota |
United States | Crossroads Cancer Center | Effingham | Illinois |
United States | Kaiser Permanente-Fremont | Fremont | California |
United States | Fresno Cancer Center | Fresno | California |
United States | Kaiser Permanente-Fresno | Fresno | California |
United States | Northwestern Medicine Cancer Center Delnor | Geneva | Illinois |
United States | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana |
United States | Jupiter Medical Center | Jupiter | Florida |
United States | Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan |
United States | Kaiser Permanente-Modesto | Modesto | California |
United States | Helen F Graham Cancer Center | Newark | Delaware |
United States | Medical Oncology Hematology Consultants PA | Newark | Delaware |
United States | Kaiser Permanente Oakland-Broadway | Oakland | California |
United States | Kaiser Permanente-Oakland | Oakland | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California |
United States | Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cordova | California |
United States | Kaiser Permanente- Marshall Medical Offices | Redwood City | California |
United States | Ascension Saint Mary's Hospital | Rhinelander | Wisconsin |
United States | Kaiser Permanente-Richmond | Richmond | California |
United States | Rohnert Park Cancer Center | Rohnert Park | California |
United States | Kaiser Permanente-Roseville | Roseville | California |
United States | The Permanente Medical Group-Roseville Radiation Oncology | Roseville | California |
United States | Kaiser Permanente Downtown Commons | Sacramento | California |
United States | Kaiser Permanente-South Sacramento | Sacramento | California |
United States | South Sacramento Cancer Center | Sacramento | California |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
United States | Siteman Cancer Center at Christian Hospital | Saint Louis | Missouri |
United States | Siteman Cancer Center-South County | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Siteman Cancer Center at Saint Peters Hospital | Saint Peters | Missouri |
United States | Kaiser Permanente-San Francisco | San Francisco | California |
United States | Kaiser Permanente-Santa Teresa-San Jose | San Jose | California |
United States | Kaiser Permanente San Leandro | San Leandro | California |
United States | Kaiser San Rafael-Gallinas | San Rafael | California |
United States | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California |
United States | Kaiser Permanente-Santa Rosa | Santa Rosa | California |
United States | Memorial Hospital East | Shiloh | Illinois |
United States | Kaiser Permanente Cancer Treatment Center | South San Francisco | California |
United States | Kaiser Permanente-South San Francisco | South San Francisco | California |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Ascension Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Kaiser Permanente-Stockton | Stockton | California |
United States | Kaiser Permanente Medical Center-Vacaville | Vacaville | California |
United States | Westchester Medical Center | Valhalla | New York |
United States | Kaiser Permanente-Vallejo | Vallejo | California |
United States | Kaiser Permanente-Walnut Creek | Walnut Creek | California |
United States | Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois |
United States | Aspirus Regional Cancer Center | Wausau | Wisconsin |
United States | Reading Hospital | West Reading | Pennsylvania |
United States | Aspirus Cancer Care - Wisconsin Rapids | Wisconsin Rapids | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
NRG Oncology | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient-reported outcomes | 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. | Up to 5 years | |
Primary | Metastasis-Free Survival (MFS) | 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. | From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years | |
Secondary | Failure-Free Survival | 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. | From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years | |
Secondary | Overall Survival | 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. | 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 | |
Secondary | MFS | 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. | From randomization to the date of distant metastasis, or death from any cause, assessed up to 15 years | |
Secondary | Incidence of Adverse Events (AEs) | 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. | Up to 15 years | |
Secondary | Urinary Incontinence domain of the Expanded Prostate Cancer Index Composite (EPIC-26) | Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life. | Up to 5 years | |
Secondary | Urinary Irritative/Obstructive domain of the Expanded Prostate Cancer Index Composite (EPIC-26) | Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life. | Up to 5 years | |
Secondary | Bowel domain of the Expanded Prostate Cancer Index Composite (EPIC-26) | Each response is standardized to a 0 to 100 scale, with higher scores indicating better health-related quality of life. | Up to 5 years | |
Secondary | Fatigue | 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. | Up to 5 years | |
Secondary | Cost | Measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-COST. | Up to 1 year |
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