PSA Level Less Than or Equal to FifteenPhase 2NCT02095145

Pomegranate-Extract Pill in Preventing Tumor Growth in Patients With Localized Prostate Cancer Undergoing Active Surveillance

A Phase 2 study testing Laboratory Biomarker Analysis, Pharmacological Study and Pomegranate-Extract Pill in people with PSA Level Less Than or Equal to Fifteen and PSA Level Less Than Ten, run by National Cancer Institute (NCI) at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This randomized phase II trial studies pomegranate-extract pill in preventing tumor growth in patients with prostate cancer that is limited to a certain part of the body (localized), who have chosen observation as their treatment plan. Read more about this study

Who is it for?: Ages 21 years and older, men only
Conditions the study is for: PSA Level Less Than or Equal to Fifteen, PSA Level Less Than Ten, Stage I Prostate Cancer AJCC v7
What is being tested?: Laboratory Biomarker Analysis, Pharmacological Study and Pomegranate-Extract Pill
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: 4 sitesUnited States
Study dates: 8 May 2014to 26 Sep 2019
Phase: Phase 2
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 21 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must have had a standard-of-care biopsy within 13 months of the baseline study visit and must have been diagnosed with low-grade, clinically localized prostate cancer (Gleason score =< 3+3 with a PSA at baseline < 10 ng/ml in participants < 70 years of age, OR Gleason score =< 3+4 with a PSA at baseline =< 15 ng/ml in participants >= 70 years of age); eligible participants will be those men who are able and willing to undergo AS with PSA monitoring and a scheduled biopsy performed at the end of the study
No concurrent treatment (hormonal, radiation or systemic chemotherapy) for prostate cancer during study enrollment is planned (unless participants demonstrate clinical evidence of prostate cancer progression such as symptoms, physical exam findings, a rapidly increasing PSA, or radiologic findings which confirm disease progression)
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
White blood cells (WBC) >= 3000/mm^3
Platelets >= 100,000 mm^3
Hemoglobin >= 10 g/dL

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Total bilirubin =< 1.5 x upper limit of institutional normal
Alkaline phosphatase =< 1.5 x upper limit of institutional normal
Aspartate aminotransferase (AST) =< 1.5 x upper limit of institutional normal
Alanine aminotransferase (ALT) =< 1.5 x upper limit of institutional normal
Serum creatinine within 1.5 x upper limit of institutional normal
Sodium 135-144 mmol/L (inclusive)
Potassium 3.2-4.8 mmol/L (inclusive)
Participants will be required to use a medically-approved method of birth control or abstinence if their sexual partner is of child-bearing potential
Participants must be willing to forego foods, beverages and supplements containing pomegranate for the duration of the study
Ability to understand, and the willingness to sign, a written informed consent document

Who cannot join

Any prior surgery to the prostate within 30 days of baseline procedures; NOTE: Biopsies are not considered surgeries
Evidence of other cancer(s) (excluding non-melanoma skin cancer) within last 5 years
Prior pelvic radiation for any reason
Participants cannot be taking 5-alpha-reductase inhibitors while on study or within 6 months of the baseline study visit
Participants may not be taking carbamazepine (tegretol)
Participants may not be receiving any other investigational agents

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History of allergic reactions attributed to compounds of similar chemical or biologic composition to PFE
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
Any significant cardiac event(s) within the 12 months prior to registration, such as episode(s) of symptomatic congestive heart failure, myocardial infarction, unstable angina pectoris or persistent, stable angina pectoris, or cardiac arrhythmia requiring medication

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Urology San Antonio Research PA
San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase IIA Exploratory, Randomized, Placebo-Controlled Trial of Pomegranate Fruit Extract/Pomx™ in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance

Read the detailed description

PRIMARY OBJECTIVES:

To determine the effect of pomegranate fruit extract (PFE) 1000 mg, taken daily for 1 year, on the plasma levels of insulin-like growth factor (IGF-1) from baseline to end of study (52 weeks) in participants undergoing active surveillance (AS) for early stage prostate cancer.

SECONDARY OBJECTIVES:

To assess compliance with a once daily oral administration of PFE versus placebo over a 52-week period of time.

II. To assess the toxicity of PFE vs. placebo when taken daily for 52 weeks (+/- 1 week).

III. To compare and correlate the effect of 52 weeks of daily dosing with PFE vs placebo on the end of study biopsy results including the presence or absence of tumor, the extent of tumor and Gleason scores.

IV. To compare and correlate the modulation of the following biomarkers with response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core, tumor tissue from a positive core, and normal tissue adjacent to tumor from a positive core; plasma: insulin-like growth factor 1/IGF binding protein 3 ratio (IGF-1/IGFBP-3 ratio); prostate tissue (normal and abnormal): apoptosis (CASPASE 3), Ki-67, 8OHdG, IGF-1R, androgen receptor, IGF-1, IGFBP-3, prostate specific antigen (PSA).

Measure PFE constituents/metabolites in plasma and urine for evidence of accumulation (trough levels): ellagic acid, dimethyl ellagic acid, dimethyl ellagic acid glucuronide (DMEAG), urolithin A, urolithin A-glucuronide, urolithin B and urolithin B-glucuronide.

VI. Measure PSA doubling time (PSA DT) in serum, using the calculation provided on the Memorial Sloan Kettering Cancer Center website.

VII. To assess the feasibility of cancer chemoprevention trials in a population of men undergoing active surveillance for prostate cancer.

VIII. Measurement of serum testosterone.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive pomegranate-extract pill orally (PO) once daily (QD) for 52 weeks (+/- 1 week).

GROUP II: Patients receive placebo PO QD for 52 weeks (+/- 1 week).

Conditions: PSA Level Less Than or Equal to Fifteen, PSA Level Less Than Ten, Stage I Prostate Cancer AJCC v7, Stage II Prostate Cancer AJCC v7, Stage IIA Prostate Cancer AJCC v7, Stage IIB Prostate Cancer AJCC v7
Being tested: Laboratory Biomarker Analysis, Pharmacological Study, Placebo, Pomegranate-Extract Pill
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laboratory Biomarker AnalysisOther
Correlative studies
Pharmacological StudyOther
Correlative studies
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO
Pomegranate-Extract PillDrug
Also called POMx
Given PO

Study groups in NCT02095145
Study group	Role	What they receive
Group I (pomegranate-extract pill)	Experimental	Patients receive pomegranate-extract pill PO QD for 52 weeks (+/- 1 week). Receives: Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Pomegranate-Extract Pill
Group II (placebo)	Placebo comparator	Patients receive placebo PO QD for 52 weeks (+/- 1 week). Receives: Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Plasma IGF-1 From Baseline to Post-Treatment
The primary endpoint for modulation of intermediate endpoint biomarkers will be the change in the plasma levels of IGF-1 by a quantitative assay (ELISA) from pre-study to post-treatment. The difference between these time points for the placebo group and the pomegranate fruit extract (PFE) group will be tested using a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test.
Measured: Baseline to 12 months

Secondary outcomes (19)

Compliance: Number of Participants Who Took Study Drug Per Protocol
Summarized by treatment arm with descriptive statistics, and tested for imbalance using Wilcoxon rank-sum test. Reported for each visit per protocol at Week 13, Week 26, Week 39, and Week 52 (end of study).
Measured: Up to 1 year
Incidence of Adverse Events Graded Per Common Terminology Criteria for Adverse Events (CTCAE)
Patient toxicity throughout the study will be summarized in several ways; the presence or absence of any toxicity, worst CTCAE grade, and strongest investigator-defined relationship will all be examined and characterized by treatment arm, and analyzed appropriately (Wilcoxon rank-sum for ordinal data, Fisher's exact test for dichotomous data, and log rank test for time to event data).
Measured: Up to 1 year
Change in Plasma Biomarker Levels From Baseline: IGFBP-3
Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Measured: Week 13, Week 26, Week 39, Week 52
Change in Plasma Biomarker Levels From Baseline: IGF-1/GFBP-3
Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Measured: Week 13, Week 26, Week 39, Week 52
Change in Total Serum Prostate Specific Antigen (PSA) From Baseline
Measured: Up to 1 year
Change in Serum Testosterone
Measured: up to 1 year
Prostate Specific Antigen Doubling Time (PSA DT)
PSA DT will be determined from PSA values obtained during study participation (baseline and weeks 13, 26, 39 and 52). The secondary endpoint of PSA DT is based on the value at study completion (week 52 or at point of early termination). However, PSA DT will be determined starting at week 26 (the earliest time point with 3 values) and week 39 and recorded. PSA doubling time is a measure based on the slope of the PSA at multiple time points. If the slope is relatively flat, the predicted doubling time could be far beyond the length of the actual study. As such, the value is not limited to the time frame over which data is collected from the participant.
Measured: up to 52 Weeks
Change in Tissue Biomarker Levels: PSA
Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core ("benign" in results), tumor tissue from a positive core ("tumor" in results), and normal tissue adjacent to tumor from a positive core ("adjacent" in results). Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Measured: Baseline to Week 52
Change in Tissue Biomarker Levels: IGF-1
Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core ("benign" in results), tumor tissue from a positive core ("tumor" in results), and normal tissue adjacent to tumor from a positive core ("adjacent" in results). Measurements for each are per nuclear ("Nuc" in results), cytoplasmic ("Cyt" in results), and cellular ("Cell" in results) basis. Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Measured: Baseline to Week 52
Change in Tissue Biomarker Levels: IGFBP-3
Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core ("benign" in results), tumor tissue from a positive core ("tumor" in results), and normal tissue adjacent to tumor from a positive core ("adjacent" in results). Measurements for each are per nuclear ("Nuc" in results), cytoplasmic ("Cyt" in results), and cellular ("Cell" in results) basis. Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Measured: Baseline to Week 52
Change in Tissue Biomarker Levels: CASP3
Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core ("benign" in results), tumor tissue from a positive core ("tumor" in results), and normal tissue adjacent to tumor from a positive core ("adjacent" in results). Measurements for each are per nuclear ("Nuc" in results), cytoplasmic ("Cyt" in results), and cellular ("Cell" in results) basis. Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Measured: Baseline to Week 52
Change in Tissue Biomarker Levels: Ki-67
Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core ("benign" in results), tumor tissue from a positive core ("tumor" in results), and normal tissue adjacent to tumor from a positive core ("adjacent" in results). Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Measured: Baseline to Week 52
Change in Tissue Biomarker Levels: IGF-Rb
Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core ("benign" in results), tumor tissue from a positive core ("tumor" in results), and normal tissue adjacent to tumor from a positive core ("adjacent" in results). Measurements for each are per nuclear ("Nuc" in results), cytoplasmic ("Cyt" in results), and cellular ("Cell" in results) basis. Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Measured: Baseline to Week 52
Change in Tissue Biomarker Levels: 8OHdG
Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core ("benign" in results), tumor tissue from a positive core ("tumor" in results), and normal tissue adjacent to tumor from a positive core ("adjacent" in results). Measurements for each are per nuclear ("Nuc" in results), cytoplasmic ("Cyt" in results), and cellular ("Cell" in results) basis. Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Measured: Baseline to Week 52
Change in Tissue Biomarker Levels: AR
Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core ("benign" in results), tumor tissue from a positive core ("tumor" in results), and normal tissue adjacent to tumor from a positive core ("adjacent" in results). Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Measured: Baseline to Week 52
Change in Levels of Pomegranate Fruit Extract (PFE) Constituents/Metabolites: Urolithin A
Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Measured: Change from Baseline at Week 13, Week 26, Week 39, and Week 52
Change in Levels of PFE Constituents/Metabolites: Urolithin B
Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Measured: Change from Baseline at Week 13, Week 26, Week 39, and Week 52
Change in Gleason Score
The Gleason Score is a grading system used to determine the aggressiveness of prostate cancer, scored 1-5 with 1 being healthy tissue and 5 being abnormal. Prostate cancers are assigned 2 scores to define the 2 most prevalent tissue types. They are added together (total range of 2-10). Typical scores fall between 6-10, the higher the overall score, the more likely the cancer will spread.
Measured: Baseline to 1 year
Change in Biopsy Tumor Involvement on Prostate Biopsy
Change in the length of biopsy cores that contained cancerous tissue from Baseline to end of study.
Measured: Baseline to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 201426 Sep 2019

First posted24 Mar 2014 (estimated)
Study start8 May 2014
Primary completion23 Jan 2018
Study completion26 Sep 2019

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 PSA Level Less Than or Equal to FifteenStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02095145
Sponsor's protocol ID: NCI-2014-00695
Other IDs: NCI-2014-00695, N01-CN-2012-00033, CO11378, UWI2013-00-01, N01CN00033, N01CN35153, P30CA014520
Status last verified: Jan 2020
First submitted: 20 Mar 2014
Last updated: 5 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIA Exploratory, Randomized, Placebo-Controlled Trial of Pomegranate Fruit Extract/Pomx™ in Subjects With Clinically Localized Prostate Cancer Undergoing Active Surveillance
ClinicalTrials.gov ID: NCT02095145
Acronym / sponsor ID: NCI-2014-00695
Conditions: PSA Level Less Than or Equal to Fifteen, PSA Level Less Than Ten, Stage I Prostate Cancer AJCC v7, Stage II Prostate Cancer AJCC v7, Stage IIA Prostate Cancer AJCC v7, Stage IIB Prostate Cancer AJCC v7
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: 8 May 2014 (actual)
Primary completion: 23 Jan 2018 (actual)
Study completion: 26 Sep 2019 (actual)
First posted: 24 Mar 2014 (estimated)
Results: Posted 5 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To determine the effect of pomegranate fruit extract (PFE) 1000 mg, taken daily for 1 year, on the plasma levels of insulin-like growth factor (IGF-1) from baseline to end of study (52 weeks) in participants undergoing active surveillance (AS) for early stage prostate cancer.

SECONDARY OBJECTIVES:

To assess compliance with a once daily oral administration of PFE versus placebo over a 52-week period of time.

II. To assess the toxicity of PFE vs. placebo when taken daily for 52 weeks (+/- 1 week).

Measure PFE constituents/metabolites in plasma and urine for evidence of accumulation (trough levels): ellagic acid, dimethyl ellagic acid, dimethyl ellagic acid glucuronide (DMEAG), urolithin A, urolithin A-glucuronide, urolithin B and urolithin B-glucuronide.

VI. Measure PSA doubling time (PSA DT) in serum, using the calculation provided on the Memorial Sloan Kettering Cancer Center website.

VII. To assess the feasibility of cancer chemoprevention trials in a population of men undergoing active surveillance for prostate cancer.

VIII. Measurement of serum testosterone.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive pomegranate-extract pill orally (PO) once daily (QD) for 52 weeks (+/- 1 week).

GROUP II: Patients receive placebo PO QD for 52 weeks (+/- 1 week).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group I (pomegranate-extract pill)	Experimental	Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Drug: Pomegranate-Extract PillPatients receive pomegranate-extract pill PO QD for 52 weeks (+/- 1 week).
Group II (placebo)	Placebo comparator	Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Other: PlaceboPatients receive placebo PO QD for 52 weeks (+/- 1 week).

Who may qualify

Ages: 21 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Participants must have had a standard-of-care biopsy within 13 months of the baseline study visit and must have been diagnosed with low-grade, clinically localized prostate cancer (Gleason score =< 3+3 with a PSA at baseline < 10 ng/ml in participants < 70 years of age, OR Gleason score =< 3+4 with a PSA at baseline =< 15 ng/ml in participants >= 70 years of age); eligible participants will be those men who are able and willing to undergo AS with PSA monitoring and a scheduled biopsy performed at the end of the study
No concurrent treatment (hormonal, radiation or systemic chemotherapy) for prostate cancer during study enrollment is planned (unless participants demonstrate clinical evidence of prostate cancer progression such as symptoms, physical exam findings, a rapidly increasing PSA, or radiologic findings which confirm disease progression)
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
White blood cells (WBC) >= 3000/mm^3
Platelets >= 100,000 mm^3

Key exclusion criteria (9 listed)

Any prior surgery to the prostate within 30 days of baseline procedures; NOTE: Biopsies are not considered surgeries
Evidence of other cancer(s) (excluding non-melanoma skin cancer) within last 5 years
Prior pelvic radiation for any reason
Participants cannot be taking 5-alpha-reductase inhibitors while on study or within 6 months of the baseline study visit
Participants may not be taking carbamazepine (tegretol)

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
Laboratory Biomarker AnalysisCorrelative studies	Other	Group I (pomegranate-extract pill), Group II (placebo)
Pharmacological StudyCorrelative studies	Other	Group I (pomegranate-extract pill), Group II (placebo)
PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO	Other	Group II (placebo)
Pomegranate-Extract PillAlso: POMxGiven PO	Drug	Group I (pomegranate-extract pill)

Primary outcome

Change in Plasma IGF-1 From Baseline to Post-Treatment
Time frame: Baseline to 12 months
The primary endpoint for modulation of intermediate endpoint biomarkers will be the change in the plasma levels of IGF-1 by a quantitative assay (ELISA) from pre-study to post-treatment. The difference between these time points for the placebo group and the pomegranate fruit extract (PFE) group will be tested using a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test.

19 secondary outcomes

Compliance: Number of Participants Who Took Study Drug Per Protocol
Time frame: Up to 1 year
Incidence of Adverse Events Graded Per Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: Up to 1 year
Change in Plasma Biomarker Levels From Baseline: IGFBP-3
Time frame: Week 13, Week 26, Week 39, Week 52
Change in Plasma Biomarker Levels From Baseline: IGF-1/GFBP-3
Time frame: Week 13, Week 26, Week 39, Week 52
Change in Total Serum Prostate Specific Antigen (PSA) From Baseline
Time frame: Up to 1 year
Change in Serum Testosterone
Time frame: up to 1 year
Prostate Specific Antigen Doubling Time (PSA DT)
Time frame: up to 52 Weeks
Change in Tissue Biomarker Levels: PSA
Time frame: Baseline to Week 52
Change in Tissue Biomarker Levels: IGF-1
Time frame: Baseline to Week 52
Change in Tissue Biomarker Levels: IGFBP-3
Time frame: Baseline to Week 52
Change in Tissue Biomarker Levels: CASP3
Time frame: Baseline to Week 52
Change in Tissue Biomarker Levels: Ki-67
Time frame: Baseline to Week 52
Change in Tissue Biomarker Levels: IGF-Rb
Time frame: Baseline to Week 52
Change in Tissue Biomarker Levels: 8OHdG
Time frame: Baseline to Week 52
Change in Tissue Biomarker Levels: AR
Time frame: Baseline to Week 52
Change in Levels of Pomegranate Fruit Extract (PFE) Constituents/Metabolites: Urolithin A
Time frame: Change from Baseline at Week 13, Week 26, Week 39, and Week 52
Change in Levels of PFE Constituents/Metabolites: Urolithin B
Time frame: Change from Baseline at Week 13, Week 26, Week 39, and Week 52
Change in Gleason Score
Time frame: Baseline to 1 year
Change in Biopsy Tumor Involvement on Prostate Biopsy
Time frame: Baseline to 1 year

Results and safety

Results posted to the registry on 5 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group I (Pomegranate-extract Pill)	15	14
Group II (Placebo)	15	15

Primary outcome: Change in Plasma IGF-1 From Baseline to Post-Treatment

Time frame: Baseline to 12 months. Mean (Standard Deviation). Unit: ng/mL

Measure	Group I (Pomegranate-extract Pill) n = 14	Group II (Placebo) n = 15
Value	19.12 (21.22)	8.54 (23.11)

Group I (Pomegranate-extract Pill) vs Group II (Placebo): p = 0.190, Wilcoxon rank-sum test
Group I (Pomegranate-extract Pill) vs Group II (Placebo): p = 0.211, t-test, 2 sided

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 52 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group I (Pomegranate-extract Pill)	2 of 14 (14.3%)	14 of 14 (100%)	0 of 14
Group II (Placebo)	2 of 15 (13.3%)	13 of 15 (86.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

David F Jarrard principal investigator

University of Wisconsin, Madison

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 9 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2020). 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?

Change in Plasma IGF-1 From Baseline to Post-Treatment (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02095145.

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 5 Feb 2020.