Localized Prostate CarcinomaNCT04870515
Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study
A study testing Best Practice, Dietary Intervention and Exercise Intervention in people with Localized Prostate Carcinoma and Prostate Adenocarcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies the effects of a diet and physical activity intervention on blood measures of lipids and insulin resistance in patients with prostate cancer undergoing radiation therapy (RT) and androgen deprivation therapy (ADT). Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Localized Prostate Carcinoma, Prostate Adenocarcinoma
- What is being tested?
- Best Practice, Dietary Intervention and Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2021to 18 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 40 years
- Histologically confirmed adenocarcinoma of the prostate, (D'Amico risk category intermediate or high risk, localized or locoregional)
- Primary treatment is RT + ADT [Zoladex, Lupron, Degarelix, and other luteinizing hormone-releasing hormone (luteinizing hormone releasing hormone [LHRH])-directed therapies] with standard RT dose and fractionation (anti-androgen monotherapy will not be allowed
- Physically able to undertake an exercise program
Who cannot join
- Advanced, metastatic disease
- Planning to join a commercial/structured diet change or fitness program
- Have significant pre-existing T2D (poor glycemic control while on medication, defined as hemoglobin A1c of >= 10 within the prior 12 months) or significant pre-existing cardiovascular disease (CVD) (myocardial infarction or stroke within prior six months)
- Physician confirmed cognitive impairment or alcohol/narcotic abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: TRIPLE-A PILOT: Actively Intercepting ADT-Induced Metabolic Aberrations in Newly Diagnosed Prostate Cancer
This clinical trial studies the effects of a diet and physical activity intervention on blood measures of lipids and insulin resistance in patients with prostate cancer undergoing radiation therapy (RT) and androgen deprivation therapy (ADT). ADT effectively slows the growth of prostate cancer cells, thereby enhancing the therapeutic effectiveness of RT. Despite the clinical gains, ADT leads to an array of side effects including insulin resistance, abnormal lipid levels, weight gain, increased visceral fat mass coupled with increased muscle wasting, and quality of life deterioration. A diet and physical activity intervention may intercept or prevent the abrupt metabolic and physiologic changes caused by androgen deprivation therapy in prostate cancer patients receiving ADT and RT.
Read the detailed description
OUTLINE:
Patients are randomized to 1 of 2 groups.
GROUP I (DIET AND PHYSICAL ACTIVITY): Patients attend 10 in-person or virtual sessions with a registered dietitian over 6 months to receive instructions on a modified DASH diet. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
GROUP II (CONTROL): Patients attend a single in-person or virtual session with a registered dietitian to receive standard lifestyle recommendations based on the United States (US) dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight maintenance.
- Being tested
- Best Practice, Dietary Intervention, Exercise Intervention, Quality-of-Life Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard lifestyle recommendations
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Receive dietary instructions
Complete aerobic and strength/resistance exercises
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (diet, physical activity) | Experimental | Patients attend 10 in-person or virtual sessions with a registered dietitian over 6 months to receive instruction on healthy dietary pattern. Patients also attend 2 one-on-one sessions with an exercise physiologist to receive instruction on aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions. Receives: Other: Dietary Intervention; Other: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Group II (standard lifestyle recommendations) | Active comparator | Patients attend a single session with a dietitian to review healthy lifestyle recommendations, including US dietary guidelines and 30 minutes of physical activity 5 days/week. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Data is reported as a percentage change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score from baseline. HOMA-IR is an index to estimate the insulin resistance of a patient. HOMA-IR is defined as (glucose (mg/dl) insulin (uIU/ml)) / 405.
Measured: 0 months, 6 months
Effects of the Intervention on ADT-induced Changes in Body Weight
Change in body weight from baseline.
Measured: 0 months, 6 months
Effects of the Intervention on ADT-induced Changes in Waist Circumference
Change in waist circumference from baseline. Waist circumference was measured at 1" above umbilicus.
Measured: 0 months, 6 months
Effects of the Intervention on ADT-induced Changes in Lean Mass
Change in lean mass from baseline. Lean mass was measured by Dual-Energy X-ray Absorptiometry (DEXA).
Measured: 0 months, 6 months
Effects of the Intervention on ADT-induced Changes in Fat Mass
Change in fat mass from baseline. Fat mass was measured by Dual-Energy X-ray Absorptiometry (DEXA).
Measured: 0 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start4 Nov 2021
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Localized Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Marian Neuhouser, Fred Hutchinson Cancer Center
- Investigators
- Marian L. Neuhouser, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870515
- Sponsor's protocol ID
- RG1121348
- Other IDs
- NCI-2021-02762, P50CA097186, 10669
- Status last verified
- Jan 2026
- First submitted
- 19 Apr 2021
- Last updated
- 9 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRIPLE-A PILOT: Actively Intercepting ADT-Induced Metabolic Aberrations in Newly Diagnosed Prostate Cancer
- ClinicalTrials.gov ID
- NCT04870515
- Acronym / sponsor ID
- RG1121348
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Posted 9 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies the effects of a diet and physical activity intervention on blood measures of lipids and insulin resistance in patients with prostate cancer undergoing radiation therapy (RT) and androgen deprivation therapy (ADT). ADT effectively slows the growth of prostate cancer cells, thereby enhancing the therapeutic effectiveness of RT. Despite the clinical gains, ADT leads to an array of side effects including insulin resistance, abnormal lipid levels, weight gain, increased visceral fat mass coupled with increased muscle wasting, and quality of life deterioration. A diet and physical activity intervention may intercept or prevent the abrupt metabolic and physiologic changes caused by androgen deprivation therapy in prostate cancer patients receiving ADT and RT.
Detailed description
OUTLINE:
Patients are randomized to 1 of 2 groups.
GROUP I (DIET AND PHYSICAL ACTIVITY): Patients attend 10 in-person or virtual sessions with a registered dietitian over 6 months to receive instructions on a modified DASH diet. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
GROUP II (CONTROL): Patients attend a single in-person or virtual session with a registered dietitian to receive standard lifestyle recommendations based on the United States (US) dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight maintenance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (diet, physical activity) | Experimental | Other: Dietary Intervention, Other: Exercise Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients attend 10 in-person or virtual sessions with a registered dietitian over 6 months to receive instruction on healthy dietary pattern. Patients also attend 2 one-on-one sessions with an exercise physiologist to receive instruction on aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions. |
| Group II (standard lifestyle recommendations) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients attend a single session with a dietitian to review healthy lifestyle recommendations, including US dietary guidelines and 30 minutes of physical activity 5 days/week. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 40 years
- Histologically confirmed adenocarcinoma of the prostate, (D'Amico risk category intermediate or high risk, localized or locoregional)
- Primary treatment is RT + ADT [Zoladex, Lupron, Degarelix, and other luteinizing hormone-releasing hormone (luteinizing hormone releasing hormone [LHRH])-directed therapies] with standard RT dose and fractionation (anti-androgen monotherapy will not be allowed
- Physically able to undertake an exercise program
Key exclusion criteria (4 listed)
- Advanced, metastatic disease
- Planning to join a commercial/structured diet change or fitness program
- Have significant pre-existing T2D (poor glycemic control while on medication, defined as hemoglobin A1c of >= 10 within the prior 12 months) or significant pre-existing cardiovascular disease (CVD) (myocardial infarction or stroke within prior six months)
- Physician confirmed cognitive impairment or alcohol/narcotic abuse
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard lifestyle recommendations | Other | Group II (standard lifestyle recommendations) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsReceive dietary instructions | Other | Group I (diet, physical activity) |
| Exercise InterventionComplete aerobic and strength/resistance exercises | Other | Group I (diet, physical activity) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (diet, physical activity), Group II (standard lifestyle recommendations) |
| Questionnaire AdministrationAncillary studies | Other | Group I (diet, physical activity), Group II (standard lifestyle recommendations) |
Primary outcome
Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 0 months, 6 months
Data is reported as a percentage change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score from baseline. HOMA-IR is an index to estimate the insulin resistance of a patient. HOMA-IR is defined as (glucose (mg/dl) insulin (uIU/ml)) / 405.
Effects of the Intervention on ADT-induced Changes in Body Weight
Time frame: 0 months, 6 months
Change in body weight from baseline.
Effects of the Intervention on ADT-induced Changes in Waist Circumference
Time frame: 0 months, 6 months
Change in waist circumference from baseline. Waist circumference was measured at 1" above umbilicus.
Effects of the Intervention on ADT-induced Changes in Lean Mass
Time frame: 0 months, 6 months
Change in lean mass from baseline. Lean mass was measured by Dual-Energy X-ray Absorptiometry (DEXA).
Effects of the Intervention on ADT-induced Changes in Fat Mass
Time frame: 0 months, 6 months
Change in fat mass from baseline. Fat mass was measured by Dual-Energy X-ray Absorptiometry (DEXA).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Marian L. Neuhouser principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Dietary Intervention and Exercise Intervention in people with Localized Prostate Carcinoma and Prostate Adenocarcinoma, run by Fred Hutchinson Cancer Center 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 9 Jan 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?
Yes. Results are posted in the registry (first posted 9 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) (time frame: 0 months, 6 months). The study lists 5 primary outcomes in all. 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 9 Jan 2026.