Safety and Efficacy of POMx Capsules in Men With Recurrent Prostate Cancer: An 18-Month Study

NCT01220817 | Completed Phase 2

• 1 other identifier: POM 2007-001
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

When given to men with recurrent prostate cancer, the investigators hypothesize that POMx is effective in slowing the rise of PSA as measured by PSA doubling time in men following initial therapy for prostate cancer. Further, the investigators believe that POMx will be shown to be safe and well tolerated.

Conditions

Recurrent Prostate Cancer

Keywords

prostate; cancer; psa; psadt; pomegranate; POMx

Outcome Measures

Primary Outcomes (1)

• Prostate specific antigen doubling time (PSADT)

  All subjects who have a baseline PSA value and at least 1 on study PSA value. The PSADT will be calculated as ln 2 (0.693)/ β (slope of the linear regression fit to ln PSA vs. time in months).

  PSADT assessed at baseline

Secondary Outcomes (2)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Safety and tolerability will be continuously assessed throughout the trial

• Objective PSA response

  PSA levels will be assessed every 3 months throughout the trial

Study Arms (2)

1 POMx capsule

ACTIVE COMPARATOR

1 POMx capsule daily

Drug: 1 POMx capsule

3 POMx capsules daily

EXPERIMENTAL

Drug: 3 POMx capsules

Interventions

3 POMx capsules DRUG

3 POMx capsules daily

3 POMx capsules daily

1 POMx capsule DRUG

1 POMx capsule daily

1 POMx capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has histologically or cytologically confirmed adenocarcinoma of the prostate.
• Subject has undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor.
• Subject with a rising PSA post-prostatectomy may consider radiation as an alternative. If subject declines radiation, he may be considered eligible in this setting.
• Subject has a rising PSA on a minimum of 3 time points each at least 1 month apart, higher than the reference value noted within 1 year of study entry and defined as:
• Absolute level of PSA \>0.4 ng/mL following surgery.
• Absolute level of PSA \>1.5 ng/mL following radiation or cryotherapy.
• Absolute level of PSA \>0.4 ng/mL for subjects treated with multiple treatment modalities (e.g., surgery + radiation, radiation + cryotherapy, etc.).
• Absolute level of PSA \> nadir + 2 following neoadjuvant hormonal therapy along with external beam radiation.
• Interim PSA values during the immediate pre-study interval may demonstrate a "fluctuation" including a decline; however, the study baseline PSA must have shown a rise within the pre-study 1 year period.
• Study baseline PSAs must be determined within 4 weeks of study entry.
• First postoperative PSA permitted if detectable.
• Subject is \>18 years or age.
• Subject has life expectancy of greater than 6 months.
• Subject has ECOG performance status 0, 1 or 2
• Subject has testosterone level of \>150 ng/mL at screening.

You may not qualify if:

• Subject has known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology.
• Subject has received any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, herbal therapies containing estrogen) for a minimum of 1 year prior to study.
• Subject has had prior or concomitant treatment with experimental drugs, high dose steroids, or any other cancer treatment within 4 weeks prior to the first dose of the study product.
• Subject has consumed more than two 8 ounce glasses of pomegranate juice per week over the past 2 months.
• Subject has a known allergy to pomegranate juice or ellagic acid.
• Subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• POM Wonderful LLC: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Paller CJ, Ye X, Wozniak PJ, Gillespie BK, Sieber PR, Greengold RH, Stockton BR, Hertzman BL, Efros MD, Roper RP, Liker HR, Carducci MA. A randomized phase II study of pomegranate extract for men with rising PSA following initial therapy for localized prostate cancer. Prostate Cancer Prostatic Dis. 2013 Mar;16(1):50-5. doi: 10.1038/pcan.2012.20. Epub 2012 Jun 12.

  PMID: 22689129 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Salivary Gland Adenoma, Pleomorphic

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael Carducci, MD

  Sidney Kimmel Cancer Center, Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 14, 2010
• Study Start: October 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 6, 2012

Record last verified: 2012-04

Locations

US (1)