Exercise and Diet for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, San Francisco (UCSF), San Francisco, CAProstate CancerExercise and Diet - Behavioral
Eligibility
18+
Male
What conditions do you have?
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Study 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.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Investigational Group
1
Participants Assigned to Exercise Therapy
1
Tocilizumab

Study Objectives

2 Primary · 17 Secondary · Reporting Duration: 1 year, 2 years and 3 years post surgery

Year 3
Annual PSA recurrence rate
Month 24
Proportion of patients with detectable levels of Prostate-specific antigen (PSA)
Month 24
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
Change in scores on the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
Change in scores on the SF-12
Change in scores on the general anxiety scale of the Patient-Reported Outcomes Measurement Information System (PROMIS)
Change in scores on the general depression scale of the Patient-Reported Outcomes Measurement Information System (PROMIS)
Change in sexual function as measured by the Expanded Prostate Cancer Index Composite Short Form (EPIC-26)
Change in urinary function as measured by the EPIC-26
Changes in perceived social support
Changes in scores on the Pittsburgh Sleep Quality Index (PSQI)
Diet recall
Intervention feasibility and acceptability (intervention arms)
Self/efficacy confidence in adopting healthy behaviors over time
Week 8
Changes in Messenger Ribonucleic Acid (mRNA) expression patterns (focusing on change between biopsy and RP)
Changes in mRNA expression patterns (focusing on change between biopsy and RP)
Biopsy

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
Investigational Group
2
Participants Assigned to Exercise Therapy
2
Tocilizumab

Trial Design

4 Treatment Groups

Arm A: Reference Group
1 of 4
Arm C (Arm A + Diet)
1 of 4
Arm D (Arm A + Exercise + Diet)
1 of 4
Arm B (Arm A + Exercise)
1 of 4

Active Control

Experimental Treatment

200 Total Participants · 4 Treatment Groups

Primary Treatment: Exercise and Diet · No Placebo Group · N/A

Arm C (Arm A + Diet)
Behavioral
Experimental Group · 1 Intervention: Exercise and Diet · Intervention Types: Behavioral
Arm D (Arm A + Exercise + Diet)
Behavioral
Experimental Group · 1 Intervention: Exercise and Diet · Intervention Types: Behavioral
Arm B (Arm A + Exercise)
Behavioral
Experimental Group · 1 Intervention: Exercise and Diet · Intervention Types: Behavioral
Arm A: Reference Group
Behavioral
ActiveComparator Group · 1 Intervention: Exercise and Diet · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise and Diet
2007
N/A
~470

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year, 2 years and 3 years post surgery

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,312 Previous Clinical Trials
11,758,126 Total Patients Enrolled
48 Trials studying Prostate Cancer
15,368 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,162,986 Total Patients Enrolled
538 Trials studying Prostate Cancer
502,966 Patients Enrolled for Prostate Cancer
Stacey Kenfield, DScPrincipal InvestigatorUniversity of California, San Francisco
Stacey A Kenfield, DScPrincipal InvestigatorUniversity of California, San Francisco

Eligibility Criteria

Age 18+ · Male Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to have a device that can connect to the internet and send text messages.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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