Prostate Cancer Clinical Trial
Official title:
A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer
Verified date | May 2022 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways may kill more tumor cells. PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.
Status | Completed |
Enrollment | 255 |
Est. completion date | May 20, 2022 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of randomization - History/physical examination with digital rectal examination of the prostate within 60 days prior to registration - Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores 2-6 within 180 days of randomization - Clinical stage T1-2a (AJCC 7th edition) within 90 days of randomization - Prostate-specific antigen (PSA) < 10 ng/mL within 60 days prior to registration; - PSA should not be obtained within 10 days after prostate biopsy - No evidence of distant metastases - No regional lymph node involvement PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire - No prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease-free for a minimum of 5 years (for example, carcinoma of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed) - No severe, active co-morbidity, defined as follows: - Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months - Transmural myocardial infarction within the last 6 months - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects - Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol - Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition - HIV testing is not required for entry into this protocol - Protocol-specific requirements may also exclude immuno-compromised patients PRIOR CONCURRENT THERAPY: - No prior radical surgery (prostatectomy), cryosurgery, or high-intensity focused ultrasonography (HIFU) for prostate cancer - No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy - No prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol (DES)), or surgical castration (orchiectomy) - No finasteride within 30 days prior to registration - Prostate-specific antigen (PSA) should not be obtained prior to 30 days after stopping finasteride - No dutasteride within 90 days prior to registration - PSA should not be obtained prior to 90 days after stopping dutasteride - No prior or concurrent cytotoxic chemotherapy for prostate cancer - Patients on Coumadin or other blood-thinning agents are eligible for this study - No concurrent 3D-conformal radiation therapy |
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute at University of Alberta | Edmonton | Alberta |
Canada | Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario |
Canada | Grand River Regional Cancer Centre at Grand River Hospital | Kitchener | Ontario |
Canada | London Regional Cancer Program at London Health Sciences Centre | London | Ontario |
Canada | Hopital Notre-Dame du CHUM | Montreal | Quebec |
United States | Rosenfeld Cancer Center at Abington Memorial Hospital | Abington | Pennsylvania |
United States | Emory Crawford Long Hospital | Atlanta | Georgia |
United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
United States | Rothman Specialty Hospital | Bensalem | Pennsylvania |
United States | UAB Comprehensive Cancer Center | Birmingham | Alabama |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Boston University Cancer Research Center | Boston | Massachusetts |
United States | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
United States | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina |
United States | University of Virginia Cancer Center | Charlottesville | Virginia |
United States | Case Comprehensive Cancer Center | Cleveland | Ohio |
United States | Urology Center of Colorado | Denver | Colorado |
United States | Fox Chase Cancer Center Buckingham | Furlong | Pennsylvania |
United States | Queen's Cancer Institute at Queen's Medical Center | Honolulu | Hawaii |
United States | Academic Urology Prostate Center | King Of Prussia | Pennsylvania |
United States | Columbia-Saint Mary's Cancer Care Center | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin |
United States | Kaiser Permanente - Division of Research - Oakland | Oakland | California |
United States | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma |
United States | Arizona Center for Cancer Care - Peoria | Peoria | Arizona |
United States | Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania |
United States | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania |
United States | Arizona Oncology Services Foundation | Phoenix | Arizona |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Rohnert Park Cancer Center | Rohnert Park | California |
United States | Kaiser Permanente Medical Center - Roseville | Roseville | California |
United States | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri |
United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
United States | Kaiser Permanente Santa Clara Medical Center | Santa Clara | California |
United States | Kaiser Permanente Medical Center - South San Francisco | South San Francisco | California |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI), NRG Oncology |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points | The co-primary endpoint is the percentage of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) bowel domain score from baseline to 1 year that exceeds 5 points (baseline - one year > 5). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other. | Baseline and one year from the end of protocol treatment | |
Primary | The Percentage of Patients With Reduction From Baseline to One-year EPIC Urinary Domain Score That Exceeds 2 Points | The co-primary endpoint is the proportion of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) urinary domain score from baseline to 1 year that exceeds 2 points (baseline - one year > 2). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other. | Baseline and one year from the end of protocol treatment | |
Secondary | Acute and Late Gastrointestinal (GI) and Genitourinary (GU) Toxicity for Each Arm | Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. An acute adverse event is defined as the first occurrence of worst severity of the adverse event =30 days after the completion of radiation therapy (RT). The high dose RT arm of Radiation Therapy Oncology Group (RTOG) study RTOG-0126 (NCT00033631) reported 1% of patients experienced grade 3+ GI/GU acute toxicity with no patient experiencing a grade 4 or 5 toxicity. If the lower confidence interval is >1%, then that arm will be further investigated for acceptability. A late adverse event is defined as the first occurrence of worst severity of adverse event >30 days after RT completion. Arms are not compared to each other. | Start of protocol treatment to one year from the end of protocol treatment | |
Secondary | Rate of PSA Failure | Failure occurs when the PSA is first noted to be 2 ng/mL or more than the current nadir value (PSA > current nadir + 2) post RT completion. Time to PSA failure is defined as time from registration to the date of PSA failure, last known follow-up (censored), or death without PSA failure (competing risk). Rate of PSA failure is estimated by the cumulative incidence method. The protocol specified that one-, two-, and five-year rates would be reported. Arms are not compared to each other. | Registration to five years | |
Secondary | Rate of Disease-free Survival (DFS) | Disease-free survival duration is time from the date of randomization to the date of documentation of disease progression or until the date of death from any cause (censored). DFS is estimated by the Kaplan-Meier method. The protocol specified that one-, two-, and five-year rates would be reported. Arms are not compared to each other. | Registration to 5 years | |
Secondary | Mean Quality Adjusted Life Years at 5 Years | Quality-adjusted survival time combines disease-free survival time and quality of life as measured by the EuroQol 5-dimensional (EQ-5D) index score. It is calculated for each patient as the weighted sum of different time episodes and added up to total quality-adjusted life years . The EQ-5D measures health-related quality of life and consists of two parts, a general health visual analog scale and 5 general health questions. The latter questions are transformed into a single index score ranging from 0 (worst health state) to 1 (best health state). Arms are not compared to each other. | Registration to 5 years from the end of protocol treatment | |
Secondary | Change From Baseline in EPIC Bowel and Urinary HRQOL as Continuous Variables at One Year | The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life and a positive change from baseline indicating improvement over time. For this endpoint, in each domain, the actual change score calculated as timepoint score - baseline score will be used as the statistic. | Baseline and one year from the end of protocol treatment | |
Secondary | The Percentage of Patients With Reduction From Baseline at One Year in EPIC Sexual Domain Score That Exceeds 11 Points | The percentage of patients with a reduction in the EPIC sexual domain score from baseline that exceeds 11 points (baseline - one year > 11). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other. | Baseline one year from the end of protocol treatment | |
Secondary | The Percentage of Patients With Reduction From Baseline at One Year in EPIC Hormonal Domain Score That Exceeds 3 Points | The percentage of patients with a reduction in the EPIC hormonal domain score from baseline that exceeds 3 points (baseline - one year > 3). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other. | Baseline and one year from the end of protocol treatment | |
Secondary | Change From Baseline in EQ-5D Scores | The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score. One, 2, and 5 years will be entered when they are available. Arms are not compared. | Baseline and one year from the end of protocol treatment | |
Secondary | Utilization of Sexual Medications/Devices Questionnaire Response Frequences | The Utilization of Sexual Medications/Devices questionaire is designed to assess the use of erectile aids among patients treated for prostate cancer. This instrument is used to complement the sexual symptom domain in the EPIC. The number of subjects responding "Yes" to the following questions are reported: "Do you have a penile prosthesis", "Have you used an medications or devices to aid or improve erections?". Arms are not compared to each other. One, 2, and 5 years will be entered when they are available. | Baseline and one year from the end of protocol treatment | |
Secondary | Genetic Markers Associated With Normal Tissue Toxicities Resulting From Radiotherapy | Study entry to 5 years from the end of protocol treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |