Accelerated Hypofractionation Radiotherapy for prostate cancer of 36.25 Gy delivered in 5 fractions will not be inferior to the standard treatment of 70.2 Gy given in 26 fractions with respect to four-year biochemical failure (PSA failure) by Phoenix definition post-treatment completion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
161
A total dose of 70.2 Gy will be delivered in 26 fractions, 2.7 Gy to the Planning Target Volume (PTV) by Intensity Modulated Radiotherapy (IMRT) with stationary gantry or rotating gantry technique.
A total dose of 36.25 Gy will be delivered in 5 fractions, 7.25 Gy each to the Planning Target Volume (PTV), by Stereotactic Body Radiotherapy (SBRT) techniques.
University of Miami
Miami, Florida, United States
Northern Sydney Local Health District - Royal North Shore Hospital
St Leonards, New South Wales, Australia
A.O.U. Città della Salute e della Scienza di Torino - University Hospital Trust of Turin
Turin, Turin, Italy
Number of Participants Achieving Four-Year Biochemical Failure.
The number of participants achieving four-year biochemical failure between both treatment arms will be reported. Biochemical Failure will be evaluated using the Phoenix definition wherein failure occurs when the Prostate Specific Antigen (PSA) is ≥ 2 ng/ml more than the lowest PSA measurement before the current one.
Time frame: Up to 4 years (After Completion of Intervention)
Number of Participants Achieving Two-Year Failure.
The number of participants achieving either biochemical or clinical failure or positive biopsy. Biochemical Failure will be evaluated using the Phoenix definition wherein failure occurs when the Prostate Specific Antigen (PSA) is ≥ 2 ng/ml more than the lowest PSA measurement before the current one. Clinical failure will be reported as any clinical evidence of local progression or recurrence. A positive biopsy will be concluded via histological evaluation.
Time frame: Up to 2 years (After Completion of Intervention)
Number of Participants Experiencing Acute Treatment-Related Toxicity
Acute treatment-related toxicity will be reported as the number of participants experiencing treatment-related grade 3 or higher gastrointestinal (GI) or genitourinary (GU) adverse events during treatment or within three (3) months after treatment completion. Toxicity will be assessed using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame: Up to 5 months (After Completion of Intervention)
Prostate Cancer Mortality Rate as Measured by Number of Deaths
The prostate cancer mortality rate will be reported as the number of deaths related to prostate cancer among participants.
Time frame: Up to 5.25 years (After Completion of Intervention)
Overall Survival
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Overall survival will be reported as the elapsed time in months from randomization to death from any cause. For surviving patients, follow-up will be censored at the date of last contact.
Time frame: Up to 5.25 years (After Completion of Intervention)
Numbers of Participants Achieving ASTRO Consensus Definition (ACD) of Biochemical Failure
The number of participants achieving American Society for Therapeutic Radiation and Oncology (ASTRO) Consensus Definition (ACD) of biochemical failure will be reported. ACD failure is defined as three consecutive rises in post-treatment PSA, measured at the specified follow-up intervals.
Time frame: Up to 5.25 years (After Completion of Intervention)
HRQOL as Assessed by MAX-PC questionnaire
Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC) from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.
Time frame: Up to 5.25 years (After Completion of Intervention)
HRQOL as Assessed by EPIC-Short Form-12 questionnaire
Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study Short Form-12 (EPIC-Short Form-12) to evaluate patient function and satisfaction after prostate cancer treatment. The questionnaire has 5 subscales (Urinary Function, Urinary Symptoms, Bowel Habits, Sexual Function and Hormonal Function). Each subscale has a total score ranging from 0-100, with higher scores representing better HRQOL.
Time frame: Up to 5.25 years (After Completion of Intervention)
Number of Participants Experiencing Late Treatment-Related Toxicity
Late treatment-related toxicity will be reported as the number of participants experiencing treatment-related grade 2 or higher gastrointestinal (GI) or genitourinary (GU) adverse events occurring more than three months after treatment completion. Toxicity will be assessed using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame: Up to 5.25 years (After Completion of Intervention)
Percentage of Participants Achieving Efficacy
Efficacy will be reported as the percentage of participants achieving biochemical or clinical failure between participants with low and early intermediate risk for prostate cancer. Biochemical Failure will be evaluated using the Phoenix definition wherein failure occurs when the Prostate Specific Antigen (PSA) is ≥ 2 ng/ml more than the lowest PSA measurement before the current one. Clinical failure will be reported as any clinical evidence of local progression or recurrence.
Time frame: Up to 2 years (After Completion of Intervention)
Average Incremental Cost Utility Score as Measured by Quality Adjusted Life Years (QALYs)
An average cost utility score per patient for each treatment arm (AHRT and EHRT) will be reported as the quality adjusted life years among participants for that treatment. Cost utility will be calculated via analysis of the costs of a given treatment and compared to the cost utility of competing treatment.
Time frame: Up to 5.25 years (After Completion of Intervention)
Percentage of Participants with Residual Tumor Post-Treatment
The percentage of participants with residual tumor on both arms will be reported. The investigators will obtain prostate tissue from participants via biopsy two years after completion of protocol tissue. Tissue will analyzed for the expression of prostate cancer biomarkers. The expression of biomarkers in the post-treatment biopsies will be compared to that in the pre-treatment prostate biopsies.
Time frame: 2.25 years