Prostate Cancer - Comparative Outcomes of New Conceptual Paradigms for Treatment (PC-CONCEPT)
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- University of Southern California
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas
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New York
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Albany, New York, United States, 11204
- New York State Department of Health
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New York, New York, United States, 10065
- Weill Cornell Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Active Surveillance (AS)
Doctor will monitor the patient without directly treating the cancer.
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Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
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Stereotactic Body Radiation Therapy (SBRT)
Radiation treatment of prostate cancer requiring less than 2 weeks of treatment.
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Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
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Intensity-Modulated Radiation Therapy (IMRT)
Radiation treatment of prostate cancer requiring more than 2 weeks of treatment.
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Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
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Partial Gland Ablation (PGA)
Prostate cancer treatment that involves only treating part of the prostate that has cancer.
Examples include, but are not limited to, high intensity focused ultrasound (HIFU) and cryotherapy.
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Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
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Radical Prostatectomy (RP)
Prostate surgery that removes the whole prostate.
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Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry
Time Frame: 8 months
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Clark's Prostate Cancer Health Worry is a 5-item questionnaire measuring treatment regret.
All items are scored 0-100, with higher scores indicating greater treatment regret.
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8 months
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Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry
Time Frame: 12 months
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Clark's Prostate Cancer Health Worry is a 5-item questionnaire measuring treatment regret.
All items are scored 0-100, with higher scores indicating greater treatment regret.
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12 months
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Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame: 8 months
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All adverse events will be graded as an event occurred, event will indicate an adverse event occurred. observations only; intervention not indicated. |
8 months
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Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame: 12 months
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All adverse events will be graded as an event occurred, event will indicate an adverse event occurred. observations only; intervention not indicated. |
12 months
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Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L
Time Frame: 8 months, 12 months
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Adjusted quality of life scores for active surveillance (AS), radical prostatectomy (RP) and partial gland ablation (PGA) at 8 and 12 months showing the mean reported score on a scale from 0-100 with a higher score indicating better function or better health.
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8 months, 12 months
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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)
Time Frame: 8 months, 12 months
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The Expanded Prostate Cancer Index Composite (EPIC-26) is a 26-item questionnaire, dichotomized by severity, assessing four domains: urinary, sexual, bowel, and hormonal function.
Each domain is scored 0-100, with higher scores indicating greater dysfunction.
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8 months, 12 months
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Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD)
Time Frame: 8 months, 12 months
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The Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) is a 4-item questionnaire measuring severity of ejaculatory dysfunction.
The 4 items are degree of bother, ejaculatory force, ejaculatory volume, and frequency of ejaculation, and the total score is measured on a scale of 1-20, with higher scores indicating greater dysfunction.
Scores were adjusted for age, race (Black, white or other), number of comorbidities (0, 1, 2, >= 3) and NCCN risk (low vs intermediate).
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8 months, 12 months
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Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC)
Time Frame: 12 months
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The Memorial Anxiety Scores for Prostate Cancer (MAX-PC) is an 18-item questionnaire measuring treatment anxiety.
Total scores ranged from 0-54, with higher scores associated with higher anxiety, the mean of patient reported MAX-PC scores by treatment group are shown below.
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12 months
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Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels
Time Frame: 8 months
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Patient PSA levels (ng/mL) will be obtained through medical record review of laboratory (blood) results.
Information below reflects the percentage of subjects that were estimated to have risk of recurrence based on their reported PSA by treatment group.
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8 months
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Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels
Time Frame: 12 months
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Patient PSA levels (ng/mL) will be obtained through medical record review of laboratory (blood) results.
Information below reflects the percentage of subjects that were estimated to have risk of recurrence based on their reported PSA by treatment group.
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12 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jim Hu, MD MPH, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-08022531 (Other Identifier: Weill Cornell Medicine Institutional Review Board)
- CER-2019C1-15682 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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