Prostate Adenocarcinoma Clinical Trial
Official title:
A Phase II Trial of Hypofractionated Radiation Therapy for Prostate Cancer With High Risk Features After Radical Prostatectomy
Verified date | September 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial studies how well hypofractionated radiation therapy works in treating participants with prostate cancer high-risk features following radical prostatectomy. 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.
Status | Active, not recruiting |
Enrollment | 52 |
Est. completion date | May 8, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed prostate adenocarcinoma at the time of surgery - Pathologic stages T2-T3b, N0-Nx-N1, M0-1 as staged by the pathology report (American Joint Committee on Cancer [AJCC] criteria 8th edition [Ed.]) - One or more high risk features including: seminal vesicle invasion, extracapsular extension, positive margins, or a PSA post surgery between 0.2 and < 2.0 - PSA values < 2 ng/ml within 90 days prior to enrollment. Obtained at least 6 weeks after surgery - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment - Patients must sign Institutional Review Board (IRB) approved study specific informed consent - Patients must complete all required pre-entry tests within the specified time frames - Patients must be able to start treatment (androgen suppression [AS] or radiation) within 120 days of study registration - Members of all races and ethnic groups are eligible for this trial - Patients from outside of the United States may participate in the study Exclusion Criteria: - Previous pelvic radiation - Prior androgen suppression therapy for prostate cancer for more than 6 months - Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed) - Prior systemic chemotherapy for prostate cancer - History of proximal urethral stricture requiring dilatation - Current and continuing anticoagulation with warfarin sodium (coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (plavix), or equivalent (unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or place markers) - Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study) - Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed) - History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | Mayo Clinic in Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Development of quality assurance process for prostate proton therapy | Up to 5 years | ||
Other | Pathologic and radiologic findings | Correlated with outcome. | Up to 5 years | |
Other | Estimation of prostate and normal structure movement | Up to 5 years | ||
Other | Dose volume relationship of normal structures with toxicity | Up to 5 years | ||
Other | Potentially, future research of pathologic risk factors | Up to 5 years | ||
Other | Possible comparison of an intensity-modulated radiation therapy (IMRT) plan with the proton therapy radiation plan | Up to 5 years | ||
Primary | Freedom from failure (FF) | Will be defined as the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), the start/re-start of salvage therapy including androgen suppression, and biochemical failure (PSA >= 0.5 ng/ml). Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. | Up to 5 years | |
Secondary | Acute grade 2 or higher and grade 3 or higher genitourinary (GU) and gastrointestinal (GI) toxicity | Will be performed using National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria. Descriptive measurements of frequency will be compiled. The maximum grade for each type of acute adverse events (AE) will be recorded for each patient. Data will be summarized as frequencies and relative frequencies. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Similarly, grade 3 or higher GU and GI events will be estimated along with overall toxicity. | Up to 5 years | |
Secondary | Grade 2 or higher and grade 3 or higher GI and GU toxicity | Will be performed using NCI-CTCAE version 4 criteria. The maximum grade for each type of acute adverse events (AE) will be recorded for each patient. Data will be summarized as frequencies and relative frequencies. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Similarly, grade 3 or higher GU and GI events will be estimated along with overall toxicity. | 3 years | |
Secondary | Local/distant failure | Will be measured from the date of the start of treatment to the date of documented local failure as determined either by clinical exam, imaging, or by prostate rebiopsy. | Start of treatment assessed up to 5 years | |
Secondary | Distant metastasis | Up to 5 years | ||
Secondary | Quality of life (QOL) | Summation of relative scores for quality of life items from the Expanded Prostate Cancer Index Composite (EPIC) instrument will be used to measure each individual's quality of life. The difference in mean scores will be assessed with the t-test. To assess changes in health-related QOL from baseline, a clinically significant difference will be defined as half of a standard deviation (SD) and at least a 10-point change. Scale score trajectories over time will be examined using stream plots and mean plots with standard deviation error bars overall. Analysis will include percent change from baseline using t-tests and generalized linear models to test for changes at each time point and non-zero slope respectfully. | Up to 5 years | |
Secondary | Impotence | Summation of relative scores for sexual function items (items 31 through 39) from the Expanded Prostate Cancer Index Composite (EPIC) instrument will be used to measure each individual's quality of life. Will be estimated as the number of patients experiencing the event of interest divided by the total number of evaluable patients. 95% confidence intervals will be calculated for each estimate. | Up to 3 years | |
Secondary | Salvage androgen suppression use | Will be estimated as the number of patients experiencing the event of interest divided by the total number of evaluable patients. 95% confidence intervals will be calculated for each estimate. | Up to 5 years | |
Secondary | Overall survival | Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% confidence intervals (CIs). | Up to 5 years | |
Secondary | Progression free survival | Will use clinical, biochemical and SAD as events. Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs. | Up to 5 years | |
Secondary | Disease-free survival | Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs. | Up to 5 years | |
Secondary | Freedom from biochemical failure (FFBF) | Will be estimated as the number of patients experiencing the event of interest divided by the total number of evaluable patients. 95% confidence intervals will be calculated for each estimate. | Up to 5 years |
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