Clinical trial NCT04890314: Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment
Official title: Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2021-05-18
Enrollment: 1953
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a diagnosis of prostate cancer who meet the inclusion and exclusion criteria will be eligible for participation in this study.

Brief summary: This study will use a population-based cohort design to study men with newly diagnosed low- and intermediate-risk prostate cancer at high-volume centers in Southern California (SCa) and New York State (NYS). Complications of contemporary treatments for prostate cancer and quality of life outcomes, such as general health, urinary, sexual, and bowel function, cancer anxiety, and treatment regret will be compared and tracked over the course of this study.

Detailed description: Prostate cancer remains the most commonly diagnosed, solid organ tumor and the second most common cause of cancer death in U.S. men. Technological advances have enabled new treatment options, such as stereotactic body radiation therapy (SBRT) and partial gland ablation (PGA). Although heavily marketed as more convenient with fewer side effects, there is an absence of high-level, comparative effective research (CER) to discern relative outcomes to traditional therapies such as active surveillance (AS), radical prostatectomy (RP) and intensity modulated radiation therapy (IMRT).

Investigators hypothesize that PGA will be associated with less reduction of urinary and sexual function compared to before treatment than both RP and IMRT. SBRT is hypothesized to be associated with less reduction of urinary and sexual function before treatment compared to RP and IMRT. SBRT is hypothesized to be associated with less reduction in bowel function compared to IMRT. PGA hypothesized to be associated with better overall quality of life at 12 months compared to AS. Investigators hypothesize PGA and SBRT will be associated with fewer adverse events compared to RP and IMRT.

The investigators will conduct a pragmatic, population-based cohort study of men with newly diagnosed low and intermediate risk prostate cancer in Southern California (SCa) and New York State (NYS) Surveillance Epidemiology and End Results (SEER) regions to bridge the evidence gap concerning adverse events and patient reported outcomes. This study will inform multiple stakeholders, who contributed to the study design. Stakeholders include prostate cancer survivors, payers, medical device manufacturers, professional organizations, community and academic prostate cancer experts and the Food and Drug Administration (FDA).

Eligibility criteria: Inclusion Criteria:

* Pathologically-confirmed clinically localized prostate adenocarcinoma with National Comprehensive Cancer Network (NCCN) low (T1-T2a, Gleason 6, Grade Group 1, PSA \<10 ng/mL) or intermediate risk (T2b-T2c or, Gleason 7, Grade Group 2 or 3 or PSA 10-20 ng/mL)72 at one of the selected hospitals in SCa and NYS
* Diagnosis date during the 18 month recruitment window
* Able to read/speak English or Spanish
* Agree to participate by completing the baseline questionnaire

Exclusion Criteria:

* Clinically metastatic disease or high-risk PCa (T3a-T4, Gleason Grade Group 4 or 5 or PSA \>20 ng/mL
* Unable to read/speak English or Spanish
* Unwilling or unable to give informed consent.

Primary outcomes:
measure: Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
timeFrame: 8 months
measure: Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
timeFrame: 12 months
measure: Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L
timeFrame: 8 months, 12 months
measure: Change in Patient-Reported Urinary Function, Urinary Incontinence, Urinary Irritation, Sexual Function, Bowel Function and Hormonal Function as Measured on Expanded Prostate Cancer Index Composite (EPIC-26)
timeFrame: 8 months, 12 months
measure: Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD)
timeFrame: 8 months, 12 months
measure: Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC)
timeFrame: 12 months
measure: Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels
timeFrame: 8 months
measure: Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels
timeFrame: 12 months
measure: Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry
timeFrame: 8 months
measure: Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Albany
country: United States
facility: New York State Department of Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jim Hu, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: