Prostate CancerNCT03999151
Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)
A study testing Exercise and Diet in people with Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
The Prostate 8-II study is a 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Exercise and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2018to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years
- Diagnosed with non-metastatic prostate cancer and choose radical prostatectomy (RP) as primary treatment.
- Able to speak and read English
- Regular access to the Internet (via a computer, tablet, or phone) and text messaging capabilities on the phone
- Ability to understand a written informed consent document, and the willingness to sign it
Who cannot join
- Cannot have neoadjuvant radiation or hormone therapy planned at time of enrollment (if enrolling >4 weeks prior to RP).
- 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:
- Heart attack
- Heart surgery, cardiac catheterization, or coronary angioplasty
- Pacemaker/implantable cardiac defibrillator/rhythm disturbance
- Heart valve disease
Show all 19Show fewer
- Heart failure
- Heart transplantation
- Congenital heart disease
- Diabetes
- Kidney (renal) disease
- Chest discomfort with exertion
- Unreasonable breathlessness
- Dizziness, fainting, or blackouts
- Ankle swelling
- Unpleasant awareness of forceful, rapid or irregular heart rate
- Burning or cramping sensations in your lower legs when walking short distance
- Men already meeting aerobic AND resistance exercise recommendations. To be eligible, must not meet at least one of the following: (1) 150 minutes per week of planned moderate aerobic exercise or 75 minutes per week of planned vigorous aerobic exercise or combination;(2) Two or more days per week of resistance exercise; (3) Eight or more resistance exercises per session
- Men who are already meeting all of the 7 prostate-specific dietary recommendations
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco (UCSF)
San Francisco, California, 94143
About this study
Official title: A Randomized Controlled Trial of Diet & Exercise Interventions Among Men With Prostate Cancer - II (Prostate 8-II)
The Prostate 8-II study is a 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To examine the effects of 2-year exercise and/or diet interventions on time to prostate-specific antigen (PSA) recurrence after RP.
SECONDARY OBJECTIVES:
- Assess the proportion of participants with PSA recurrence at 6-, 12-and 24-months post-surgery.
II. To examine quality of life (QOL) across intervention groups over time. Outcomes will include sexual and urinary function, anxiety, depression, and overall QOL assessed at all timepoints.
III. To examine intervention feasibility measured by intervention component use.
IV. To examine exercise and diet behaviors across groups over time using patient reported data and accelerometer data.
EXPLORATORY OBJECTIVES:
- To examine mRNA expression pathways/scores in prostate tissue at RP accounting for baseline factors.
II. To examine Decipher prognostic scores in RP tissue, accounting for baseline factors.
III. To examine longitudinal changes in PSA from baseline to 12 and 24 months. IV. To examine intervention acceptability (self-report: surveys and/or interviews).
- To examine the effect of the interventions on exercise and diet confidence (self-report from surveys and coaching calls). Additionally, investigators will also examine other behavioral constructs in a similar manner (social support, perceived barriers, use of change strategies).
VI. To examine changes in blood biomarkers across groups over time, including metabolic markers, CRP, HbA1c, and lipid panel.
VII. To examine changes in body weight, and waist and hip circumference across groups over time.
The Prostate 8-II study enrolls participants up to 8 weeks prior to surgery. Participants may continue the intervention from time of study entry to 96 weeks after RP surgery.
All participants will receive Group A educational materials and tools, but these will be distributed at different times based on group assignment.
The remaining 3 groups will receive different combinations of exercise (Group B), diet (Group C) and exercise and diet (Group D) tools. Participants 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. Participants 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. Following the completion of the intervention, participant's treatment and disease status will be collected on a yearly basis, for up to 3 additional years.
- Conditions
- Prostate Cancer
- Being tested
- Exercise and Diet
- Keywords
- Exercise, Diet, Lifestyle, Digital, Text messaging, Coach
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and DietBehavioural
Behavioral program provides access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Reference Group | Active comparator | 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. Receives: Behavioral: Exercise and Diet |
| Arm B (Arm A + Exercise) | Experimental | 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. Receives: Behavioral: Exercise and Diet |
| Arm C (Arm A + Diet) | Experimental | 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. Receives: Behavioral: Exercise and Diet |
| Arm D (Arm A + Exercise + Diet) | Experimental | 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. Receives: Behavioral: Exercise and Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Time to prostate-specific antigen recurrence
The median time in months to PSA recurrence after surgery will be evaluated using prespecified biochemical recurrence (2x PSA ≥ 0.2) and detectable (2x PSA ≥ 0.03) PSA thresholds, at the time of analysis. A log-rank test to evaluate the time to recurrence among groups and multivariate Cox proportional hazards regression will be used to obtain a hazard ratio for the time to recurrence.
Measured: Up to 5 years post-surgery
Secondary outcomes (12)
Proportion of participants with PSA recurrence over time
The proportion of participants by group with documented PSA recurrence at months 6, 12 and 24 months post-surgery will be reported along with corresponding 95% confidence intervals.
Measured: Up to 24 months post-surgery
Mean scores on the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) over time.
The EPIC-26 will be used to determine the impact of quality of life issues on the sexual function domain. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL).
Measured: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the urinary function domain of the EPIC-26 over time.
The EPIC-26 will be used to determine the impact of quality of life issues on the urinary function domain. Response options for each EPIC item form a Likert scale, and the raw score of each item is then transformed linearly to a 0-100 scale. Multiple items are combined and then averaged to form the domain scores and total score at each time point also ranging from 0-100, with higher scores representing better health related quality of life (HRQOL).
Measured: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the general anxiety scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) over time.
General anxiety items usually has five response options ranging in value from one to five with a higher value indicating a greater degree of anxiety. The total raw score is the sum the values of the response to each question, and then converted to a scaled T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.
Measured: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) over time.
Memorial Anxiety Scale for Prostate Cancer (MAX-PC) - 18 items assessing prostate cancer anxiety, PSA anxiety, and fear of recurrence; range 0-54; smaller number is better.
Measured: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the general depression scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) over time.
General depression items usually has five response options ranging in value from one to five with a higher value indicating a greater degree of depression. The total raw score is the sum the values of the response to each question, and then converted to a scaled T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.
Measured: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the 12-Item Short Form Health Survey (SF-12) over time.
The SF-12 is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. The SF-12 consists of a subset of 12 items from the SF-36® Health Survey (SF-36) and measures two composite outcomes assessing mental health composite score (MCS) and physical health composite scores (PCS). The PCS \& MCS are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The absolute change in item score by group from baseline up to 12 months was used to assess the quality of life/psychosocial impact on the patients with a larger scores indicating a greater degree of change on physical and mental health.
Measured: Baseline, and 6 months, 12 months, and 24 months post-surgery
Changes in recorded physical activity over time
Patients will wear an Actigraph GT3X+ accelerometer on their wrist for 7 consecutive days to measure physical activity
Measured: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the Godin-Shephard Leisure-Time Physical Activity Questionnaire over time.
The Godin-Shephard Leisure-Time Physical Activity Questionnaire measures the frequency and duration of various types of physical activity (strenuous, moderate, light) and each is weighted by multiplying the frequency by a corresponding multiplier (x9, x5, x3 respectively) during a typical 7-Day period. The weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). A score of 24 units or more indicates a status of "Active", 14 - 23 units "Moderately Active" and < 14 units "Insufficiently Active/Sedentary".
Measured: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores in Harvard Food Frequency Questionnaire (FFQ) over time
The FFQ is a self-administered questionnaire to assess intake of various nutrients. Nutrient intakes are computed by assigning a daily frequency
Measured: Baseline, and 6 months, 12 months, and 24 months post-surgery
Frequency of responses on the Intervention feasibility (intervention arms)
Various metrics for study feasibility (e.g., text message, portal, and coaching use) will be measured over time. Descriptive data across arms will be reported.
Measured: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the Pittsburgh Sleep Quality Index (PSQI) over time.
In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality
Measured: Baseline, and 6 months, 12 months, and 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start11 May 2018
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stacey A Kenfield, DSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999151
- Sponsor's protocol ID
- 175513-HDFCCC
- Other IDs
- NCI-2018-02347, 5R01CA207749-05
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2019
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Diet & Exercise Interventions Among Men With Prostate Cancer - II (Prostate 8-II)
- ClinicalTrials.gov ID
- NCT03999151
- Acronym / sponsor ID
- 175513-HDFCCC
- Conditions
- Prostate Cancer
- Keywords
- Exercise, Diet, Lifestyle, Digital, Text messaging, Coach
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 May 2018 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Prostate 8-II study is a 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
PRIMARY OBJECTIVE:
- To examine the effects of 2-year exercise and/or diet interventions on time to prostate-specific antigen (PSA) recurrence after RP.
SECONDARY OBJECTIVES:
- Assess the proportion of participants with PSA recurrence at 6-, 12-and 24-months post-surgery.
II. To examine quality of life (QOL) across intervention groups over time. Outcomes will include sexual and urinary function, anxiety, depression, and overall QOL assessed at all timepoints.
III. To examine intervention feasibility measured by intervention component use.
IV. To examine exercise and diet behaviors across groups over time using patient reported data and accelerometer data.
EXPLORATORY OBJECTIVES:
- To examine mRNA expression pathways/scores in prostate tissue at RP accounting for baseline factors.
II. To examine Decipher prognostic scores in RP tissue, accounting for baseline factors.
III. To examine longitudinal changes in PSA from baseline to 12 and 24 months. IV. To examine intervention acceptability (self-report: surveys and/or interviews).
- To examine the effect of the interventions on exercise and diet confidence (self-report from surveys and coaching calls). Additionally, investigators will also examine other behavioral constructs in a similar manner (social support, perceived barriers, use of change strategies).
VI. To examine changes in blood biomarkers across groups over time, including metabolic markers, CRP, HbA1c, and lipid panel.
VII. To examine changes in body weight, and waist and hip circumference across groups over time.
The Prostate 8-II study enrolls participants up to 8 weeks prior to surgery. Participants may continue the intervention from time of study entry to 96 weeks after RP surgery.
All participants will receive Group A educational materials and tools, but these will be distributed at different times based on group assignment.
The remaining 3 groups will receive different combinations of exercise (Group B), diet (Group C) and exercise and diet (Group D) tools. Participants 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. Participants 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. Following the completion of the intervention, participant's treatment and disease status will be collected on a yearly basis, for up to 3 additional years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: Reference Group | Active comparator | Behavioral: Exercise and DietArm 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. |
| Arm B (Arm A + Exercise) | Experimental | Behavioral: Exercise and DietArm 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. |
| Arm C (Arm A + Diet) | Experimental | Behavioral: Exercise and DietArm 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. |
| Arm D (Arm A + Exercise + Diet) | Experimental | Behavioral: Exercise and DietArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >=18 years
- Diagnosed with non-metastatic prostate cancer and choose radical prostatectomy (RP) as primary treatment.
- Able to speak and read English
- Regular access to the Internet (via a computer, tablet, or phone) and text messaging capabilities on the phone
- Ability to understand a written informed consent document, and the willingness to sign it
Key exclusion criteria (19 listed)
- Cannot have neoadjuvant radiation or hormone therapy planned at time of enrollment (if enrolling >4 weeks prior to RP).
- 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:
- Men already meeting aerobic AND resistance exercise recommendations. To be eligible, must not meet at least one of the following: (1) 150 minutes per week of planned moderate aerobic exercise or 75 minutes per week of planned vigorous aerobic exercise or combination;(2) Two or more days per week of resistance exercise; (3) Eight or more resistance exercises per session
- Men who are already meeting all of the 7 prostate-specific dietary recommendations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and DietBehavioral program provides access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D) | Behavioural | Arm A: Reference Group, Arm B (Arm A + Exercise), Arm C (Arm A + Diet), Arm D (Arm A + Exercise + Diet) |
Primary outcome
Median Time to prostate-specific antigen recurrence
Time frame: Up to 5 years post-surgery
The median time in months to PSA recurrence after surgery will be evaluated using prespecified biochemical recurrence (2x PSA ≥ 0.2) and detectable (2x PSA ≥ 0.03) PSA thresholds, at the time of analysis. A log-rank test to evaluate the time to recurrence among groups and multivariate Cox proportional hazards regression will be used to obtain a hazard ratio for the time to recurrence.
12 secondary outcomes
Proportion of participants with PSA recurrence over time
Time frame: Up to 24 months post-surgery
Mean scores on the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) over time.
Time frame: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the urinary function domain of the EPIC-26 over time.
Time frame: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the general anxiety scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) over time.
Time frame: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the Memorial Anxiety Scale for Prostate Cancer (MAX-PC) over time.
Time frame: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the general depression scale of the Patient-Reported Outcomes Measurement Information System (PROMIS) over time.
Time frame: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the 12-Item Short Form Health Survey (SF-12) over time.
Time frame: Baseline, and 6 months, 12 months, and 24 months post-surgery
Changes in recorded physical activity over time
Time frame: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the Godin-Shephard Leisure-Time Physical Activity Questionnaire over time.
Time frame: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores in Harvard Food Frequency Questionnaire (FFQ) over time
Time frame: Baseline, and 6 months, 12 months, and 24 months post-surgery
Frequency of responses on the Intervention feasibility (intervention arms)
Time frame: Baseline, and 6 months, 12 months, and 24 months post-surgery
Mean scores on the Pittsburgh Sleep Quality Index (PSQI) over time.
Time frame: Baseline, and 6 months, 12 months, and 24 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey A Kenfield, DSc principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Diet in people with Prostate Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Time to prostate-specific antigen recurrence (time frame: Up to 5 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.