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| ID | Type | Description | Link |
|---|---|---|---|
| CER-2019C1-15682 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute | |
| 20-08022531 | Other Identifier | Weill Cornell Medicine Institutional Review Board |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Surveillance (AS) | Doctor will monitor the patient without directly treating the cancer. |
| |
| Stereotactic Body Radiation Therapy (SBRT) | Radiation treatment of prostate cancer requiring less than 2 weeks of treatment. |
| |
| Intensity-Modulated Radiation Therapy (IMRT) | Radiation treatment of prostate cancer requiring more than 2 weeks of treatment. |
| |
| 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. |
| |
| Radical Prostatectomy (RP) | Prostate surgery that removes the whole prostate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-reported questionnaire | Other | Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | All adverse events will be graded as an event occurred, event will indicate an adverse event occurred. observations only; intervention not indicated. | 8 months |
| Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | All adverse events will be graded as an event occurred, event will indicate an adverse event occurred. observations only; intervention not indicated. | 12 months |
| Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L | 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. | 8 months, 12 months |
| 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) | 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. | 8 months, 12 months |
| Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) | 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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Inclusion Criteria:
Exclusion Criteria:
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Subjects with a diagnosis of prostate cancer who meet the inclusion and exclusion criteria will be eligible for participation in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Jim Hu, MD MPH | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| University of Kansas |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Surveillance (AS) | Doctor will monitor the patient without directly treating the cancer. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
| FG001 | Stereotactic Body Radiation Therapy (SBRT) | Radiation treatment of prostate cancer requiring less than 2 weeks of treatment. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
| FG002 | Intensity-Modulated Radiation Therapy (IMRT) | Radiation treatment of prostate cancer requiring more than 2 weeks of treatment. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
| FG003 | 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. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
| FG004 | Radical Prostatectomy (RP) | Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This cohort includes men diagnosed with low or intermediate risk prostate cancer in New York State or Southern California between November 1, 2020 and January 31, 2023. Men took a baseline survey at the time of recruitment into the study and two follow-up surveys 8 and 12 months later
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Surveillance (AS) | Doctor will monitor the patient without directly treating the cancer. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
| BG001 | Stereotactic Body Radiation Therapy (SBRT) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | All adverse events will be graded as an event occurred, event will indicate an adverse event occurred. observations only; intervention not indicated. | Only subjects who returned 8 month surveys are included in the overall number of participants analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | 8 months |
|
The occurrence of treatment complications indicating an adverse event were patient-reported complications based on survey questions asked on both month 8 and month 12 surveys.
The occurrence of treatment complications was documented as an event that occurred or as a non event. The data below represents the total number of subjects that reported a complication event by treatment group at both time points.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Surveillance (AS) | Doctor will monitor the patient without directly treating the cancer. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| complication | Renal and urinary disorders | Non-systematic Assessment | 8 Months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jim C. Hu | Weill Cornell Medicine | (646) 962-6363 | jch9011@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2021 | Dec 24, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 8 months, 12 months |
| Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC) | 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. | 12 months |
| Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 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. | 8 months |
| Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 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. | 12 months |
| Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 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. | 8 months |
| Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 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. | 12 months |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| New York State Department of Health | Albany | New York | 11204 | United States |
| Weill Cornell Medicine | New York | New York | 10065 | United States |
Radiation treatment of prostate cancer requiring less than 2 weeks of treatment. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
| BG002 | Intensity-Modulated Radiation Therapy (IMRT) | Radiation treatment of prostate cancer requiring more than 2 weeks of treatment. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
| BG003 | 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. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
| BG004 | Radical Prostatectomy (RP) | Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Stereotactic Body Radiation Therapy (SBRT) |
Radiation treatment of prostate cancer requiring less than 2 weeks of treatment. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
| OG002 | Intensity-Modulated Radiation Therapy (IMRT) | Radiation treatment of prostate cancer requiring more than 2 weeks of treatment. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
| OG003 | 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. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
| OG004 | Radical Prostatectomy (RP) | Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. |
|
|
| Primary | Assessing Percentage of Participants Who Reported Adverse Events Following Treatment by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | All adverse events will be graded as an event occurred, event will indicate an adverse event occurred. observations only; intervention not indicated. | subjects who returned 12 month surveys are included in the overall number of participants analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
|
|
| Primary | Change in Patient-Reported Quality of Life as Measured on EQ-5D-5L | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 8 months, 12 months |
|
|
|
| Primary | 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) | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 8 months, 12 months |
|
|
|
| Primary | Change in Ejaculatory Function as Measured on Male Sexual Health Questionnaire - Ejaculatory Function and Related Distress (MSHQ-EjD) | 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). | Posted | Mean | 95% Confidence Interval | score on a scale | 8 months, 12 months |
|
|
|
| Primary | Patient-Reported Anxiety Based on Memorial Anxiety Prostate Cancer Questionnaire (MAX-PC) | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| Primary | Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 8 months |
|
|
|
| Primary | Assessment of Cancer Recurrence Following Treatment as Measured by Prostate Specific Antigen Levels | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
|
|
| Primary | Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 8 months |
|
|
|
| Primary | Assessment of Treatment Regret as Measured on Clark's Prostate Cancer Health Worry | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 months |
|
|
|
| 0 |
| 625 |
| 0 |
| 625 |
| 55 |
| 625 |
| EG001 | Stereotactic Body Radiation Therapy (SBRT) | Radiation treatment of prostate cancer requiring less than 2 weeks of treatment. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. | 0 | 226 | 0 | 226 | 22 | 226 |
| EG002 | Intensity-Modulated Radiation Therapy (IMRT) | Radiation treatment of prostate cancer requiring more than 2 weeks of treatment. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. | 0 | 218 | 0 | 218 | 19 | 218 |
| EG003 | 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. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. | 0 | 139 | 0 | 139 | 32 | 139 |
| EG004 | Radical Prostatectomy (RP) | Prostate surgery that removes the whole prostate. Patient-reported questionnaire: Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment. | 0 | 745 | 0 | 745 | 150 | 745 |
| Complication | Renal and urinary disorders | Non-systematic Assessment | 12 Months |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| 12 Months |
|
| 12 Months Urinary Function |
|
| 8 Months Urinary Incontinence |
|
| 12 Months Urinary Incontinence |
|
| 8 Months Urinary Irritation |
|
| 12 Months Urinary Irritation |
|
| 8 Months Sexual Function |
|
| 12 Months Sexual Function |
|
| 8 Months Bowel Function |
|
| 12 Months Bowel Function |
|
| 8 Months Hormone Function |
|
| 12 Months Hormone Function |
|
| 12 Months |
|