Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase II Study Evaluating Pomegranate Juice In Patients With Recurrent Adenocarcinoma Of The Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00060086
• Other study ID #: 11-001265
• Secondary ID: UCLA-0210049CDR0
• Status: Completed
• Phase: N/A
• Start date: November 30, 2004
• Est. completion date: May 25, 2021

Study information

• Verified date: June 2021
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Determine whether pomegranate juice can decrease or slow rising prostate-specific antigen (PSA) levels in patients who have undergone radical prostatectomy or radiotherapy for adenocarcinoma of the prostate.

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

PROJECTED ACCRUAL: A total of 29-40 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	POM Wonderful LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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