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Diet and Exercise for Prostate Cancer (Prostate 8-II Trial)

N/A
Waitlist Available
Led By Stacey Kenfield, DSc
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with non-metastatic prostate cancer and choose radical prostatectomy (RP) as primary treatment.
Age >=18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Prostate 8-II Trial Summary

This trial is testing different ways to help men with prostate cancer make lifestyle changes before surgery. The goal is to see if these changes can improve outcomes.

Who is the study for?
This trial is for men over 18 with non-metastatic prostate cancer who've chosen surgery (radical prostatectomy) and can read English. They need internet access and text messaging. It's not for those already following exercise guidelines, planning radiation or hormone therapy before surgery, or have health issues that make exercise risky without doctor approval.Check my eligibility
What is being tested?
The Prostate 8-II study tests different diet and exercise educational tools on biological outcomes, clinical recovery, and life quality in men undergoing prostate cancer surgery. Participants are randomly assigned to various combinations of these interventions.See study design
What are the potential side effects?
Since the interventions involve diet and exercise education rather than medication, typical side effects associated with drugs aren't expected. However, participants may experience general discomforts related to new physical activities.

Prostate 8-II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have prostate cancer and am choosing surgery as my primary treatment.
Select...
I am 18 years old or older.

Prostate 8-II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annual PSA recurrence rate
Proportion of patients with detectable levels of Prostate-specific antigen (PSA)
Secondary outcome measures
Change in Harvard Food Frequency Questionnaire (FFQ) over time
Change in physical activity over time
Change in scores on the Godin-Shephard Leisure-Time Physical Activity Questionnaire
+13 more

Prostate 8-II Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm D (Arm A + Exercise + Diet)Experimental Treatment1 Intervention
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.
Group II: Arm C (Arm A + Diet)Experimental Treatment1 Intervention
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.
Group III: Arm B (Arm A + Exercise)Experimental Treatment1 Intervention
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.
Group IV: Arm A: Reference GroupActive Control1 Intervention
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 10-week text messaging program focused on recovery after radical prostatectomy surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise and Diet
2007
N/A
~470

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,267 Total Patients Enrolled
51 Trials studying Prostate Cancer
16,829 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,949 Total Patients Enrolled
560 Trials studying Prostate Cancer
506,969 Patients Enrolled for Prostate Cancer
Stacey Kenfield, DScPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Exercise and Diet Clinical Trial Eligibility Overview. Trial Name: NCT03999151 — N/A
Prostate Cancer Research Study Groups: Arm D (Arm A + Exercise + Diet), Arm A: Reference Group, Arm C (Arm A + Diet), Arm B (Arm A + Exercise)
Prostate Cancer Clinical Trial 2023: Exercise and Diet Highlights & Side Effects. Trial Name: NCT03999151 — N/A
Exercise and Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT03999151 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period still open for this investigation?

"Correct. Data hosted on clinicaltrials.gov reveals that this research is recruiting, having been posted on May 11th 2018 and last updated August 11th 2022. The project requires 200 volunteers to be enrolled at a single site."

Answered by AI

What is the primary purpose of this investigation?

"This trial aims to evaluate the Annual Prostate-Specific Antigen Recurrence Rate over a 6 and 24 month period. Secondary objectives include gauging changes in social support, mRNA expression patterns between biopsy and radical prostatectomy tissue samples, as well as scores on the General Depression Scale of Patient Reported Outcomes Measurement Information System (PROMIS)."

Answered by AI

How many participants are currently enrolled in this clinical experiment?

"Affirmative. According to the clinicaltrial.gov database, this medical study is actively accepting applicants who meet its criteria. The trial was first posted on May 11th 2018 and has been updated most recently on August 11th 2022; 200 patients need to be recruited from 1 centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)
2018. "Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03999151.
~86 spots leftby Aug 2028
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