Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

NCT00060086 | Completed

• 3 other identifiers: 11-001265UCLA-0210049CDR0000299439
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Pomegranate juice may contain substances that decrease or slow the rise of prostate-specific antigen (PSA) levels and may be effective in delaying or preventing recurrent prostate cancer. PURPOSE: This phase II trial is studying how well pomegranate juice works in decreasing or slowing the rise of PSA levels in patients who have undergone radiation therapy or surgery for prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy, in terms of overall response rate, measured by serum prostate-specific antigen (PSA) levels every 3 months

  Evaluated every 3 months for 18 months

Study Arms (1)

Pomegranate Juice

EXPERIMENTAL

Subjects are given oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.

Dietary Supplement: pomegranate juice

Interventions

pomegranate juice DIETARY_SUPPLEMENT

Subjects receive oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.

Pomegranate Juice

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate
• Must have undergone prior surgery or radiotherapy for the primary tumor
• Documented rising prostate-specific antigen (PSA) level, defined by the following criteria:
• Absolute level of PSA at least 0.2 ng/mL but less than 5.0 ng/mL
• Rising PSA level must be confirmed at least 1 week later
• Adequate PSA time points to calculate a PSA doubling time
• Gleason score no greater than 7
• Age 18 and over
• Performance status ECOG 0-1
• Life expectancy at least 6 months
• No other malignancy within the past 5 years except nonmelanoma skin cancer
• No other serious concurrent systemic medical disorders that would preclude study compliance
• No known allergy to pomegranate juice
• More than 4 weeks since prior participation in another experimental study

You may not qualify if:

• nodal involvement
• evidence of metastatic disease
• prior hormonal therapy
• concurrent hormonal therapy for rising PSA levels after initial therapy for prostate cancer
• concurrent participation in another experimental study
• other concurrent systemic or local therapy for prostate cancer
• initiation or discontinuation of any new nutritional or dietary supplements during study participation

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• POM Wonderful LLC: collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1738, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Allan Pantuck, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: November 30, 2004
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: June 4, 2021

Record last verified: 2021-06

Locations

US (1)