Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Behavioral: Exercise and Diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Randomized Controlled Trial of Diet & Exercise Interventions Among Men With Prostate Cancer - II (Prostate 8-II) |
Actual Study Start Date : | May 11, 2018 |
Estimated Primary Completion Date : | July 31, 2022 |
Estimated Study Completion Date : | July 31, 2024 |
Arm | Intervention/treatment |
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Active Comparator: Arm A: Reference Group
Arm A will receive print educational materials about the benefits of exercise and diet for men with prostate cancer, with recommendations geared at men living with prostate cancer, mailed around the date of surgery. They also receive a 9-week text messaging program focused on recovery after radical prostatectomy surgery.
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Behavioral: Exercise and Diet
This Phase 2, open-label, four-arm randomized controlled trial (RCT) will investigate the effects of a 2-year behavioral program providing access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D) in 200 men with histologically confirmed low-risk prostate adenocarcinoma who choose radical prostatectomy as treatment.
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Experimental: Arm B (Arm A + Exercise)
Arm B receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise habits and various tools, such as the ability to track exercise; additional educational print materials on exercise; additional text messages over 2 years that supports healthy exercise habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years.
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Behavioral: Exercise and Diet
This Phase 2, open-label, four-arm randomized controlled trial (RCT) will investigate the effects of a 2-year behavioral program providing access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D) in 200 men with histologically confirmed low-risk prostate adenocarcinoma who choose radical prostatectomy as treatment.
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Experimental: Arm C (Arm A + Diet)
Arm C receives the following: Arm A material plus access to an online portal with additional educational materials to help improve diet habits and various tools, such as the ability to track diet; additional educational print materials on diet; additional text messages over 2 years that supports healthy diet habits; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.
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Behavioral: Exercise and Diet
This Phase 2, open-label, four-arm randomized controlled trial (RCT) will investigate the effects of a 2-year behavioral program providing access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D) in 200 men with histologically confirmed low-risk prostate adenocarcinoma who choose radical prostatectomy as treatment.
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Experimental: Arm D (Arm A + Exercise + Diet)
Arm D receives the following: Arm A material plus access to an online portal with additional educational materials to help improve exercise and diet habits and various tools, such as the ability to track exercise and diet; additional educational print materials on exercise and diet; additional text messages over 2 years that supports healthy exercise and diet habits; a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with an exercise coach over 2 years; and a 1-hour phone session at the start of the study followed by eight 30-minute quarterly phone sessions with a diet coach over 2 years.
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Behavioral: Exercise and Diet
This Phase 2, open-label, four-arm randomized controlled trial (RCT) will investigate the effects of a 2-year behavioral program providing access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D) in 200 men with histologically confirmed low-risk prostate adenocarcinoma who choose radical prostatectomy as treatment.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Men who have contraindications to exercise based the American College of Sports Medicine 2016 Exercise pre-participation screening criteria (https://www.ncbi.nlm.nih.gov/pubmed/26473759), and who do not receive a physician clearance to participate in the moderate to vigorous intensity physical activity with one or more of the following self-reported conditions:
Contact: Stacey Kenfield, DSc | (415) 476-5392 | Stacey.Kenfield@ucsf.edu |
United States, California | |
University of California, San Francisco (UCSF) | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Imelda Tenggara 415-353-7348 Imelda.tenggara@ucsf.edu | |
Sub-Investigator: Peter Carroll, MD, MPH | |
Sub-Investigator: Matthew Cooperberg, MD, MPH | |
Sub-Investigator: June Chan, ScD | |
Sub-Investigator: Erin Van Blarigan, ScD | |
Sub-Investigator: Rebecca Graff, ScD |
Principal Investigator: | Stacey Kenfield, DSc | University of California, San Francisco |
Tracking Information | |||||
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First Submitted Date ICMJE | June 21, 2019 | ||||
First Posted Date ICMJE | June 26, 2019 | ||||
Last Update Posted Date | August 20, 2020 | ||||
Actual Study Start Date ICMJE | May 11, 2018 | ||||
Estimated Primary Completion Date | July 31, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Genomic signature changes [ Time Frame: From baseline to up to 8 weeks ] Assessment of genomic classifiers, using the 1.4 million marker Affymetrix 1.0 Human Exon Array, in FFPE (formalin-fixed paraffin embedded) prostate biopsy and radical prostatectomy tissue. Each score ranges from 0 to 100 and can be interpreted as a probability of progression.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||
Brief Title ICMJE | Diet and Exercise Interventions Among Men With Prostate Cancer | ||||
Official Title ICMJE | A Randomized Controlled Trial of Diet & Exercise Interventions Among Men With Prostate Cancer - II (Prostate 8-II) | ||||
Brief Summary | The Prostate 8-II study is a 2-year randomized controlled trial of testing different combinations of educational and supportive tools related to diet and exercise to evaluate biological, clinical, and quality of life outcomes in men choosing radical prostatectomy as treatment for prostate cancer. | ||||
Detailed Description | This is a PI initiated, randomized controlled trial of four exercise and diet interventions among 200 men opting for radical prostatectomy for prostate cancer. The Prostate 8-II study enrolls men up to 8 weeks prior to surgery and participants remain on study for 24 cycles after surgery (1 cycle=28 days). After obtaining written informed consent, enrolled subjects will be scheduled for the baseline assessments. All participants will receive Group A educational materials and tools, but these will be distributed at different times based on group assignment. The other 3 groups will receive different combinations of exercise (Group B), diet (Group C) and exercise and diet (Group D) tools. Men in all arms will be asked to complete questionnaires at baseline, pre-surgery, and at cycles 6 12 & 24 post-surgery, and complete blood and urine collection, diet recall, and accelerometer measurement at select time points. Specimens from biopsy and radical prostatectomy will be reviewed by the investigators' collaborator, GenomeDx, for RNA characterization and assessment of the genomic risk scores. Patients will be followed for 30 days after completion of the 2-year 24-cycle intervention period or removal from the study, or until death, whichever occurs first for any treatment-related adverse events. Following the completion of the intervention, we will follow the patient's treatment and disease status on a yearly basis, for 3 more years. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Prostate Cancer | ||||
Intervention ICMJE | Behavioral: Exercise and Diet
This Phase 2, open-label, four-arm randomized controlled trial (RCT) will investigate the effects of a 2-year behavioral program providing access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D) in 200 men with histologically confirmed low-risk prostate adenocarcinoma who choose radical prostatectomy as treatment.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
200 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 31, 2024 | ||||
Estimated Primary Completion Date | July 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03999151 | ||||
Other Study ID Numbers ICMJE | 175513-HDFCCC NCI-2018-02347 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of California, San Francisco | ||||
Study Sponsor ICMJE | University of California, San Francisco | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University of California, San Francisco | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |