Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer

NCT00336934 | Completed DMC

• 4 other identifiers: CDR0000480402P30CA016042ROLL-GUP-0205-1UCLA-0507059-01
• Study Type: interventional
• Target: 183
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Pomegranate extract may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after surgery or radiation therapy for localized prostate cancer. PURPOSE: This randomized trial is studying how well pomegranate extract works in treating patients with rising PSA levels after surgery or radiation therapy for localized prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Objective response

  12 months

Secondary Outcomes (2)

• Response duration

  12 months

• Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times

  12 months

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral pomegranate extract daily.

Dietary Supplement: pomegranate juice

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo daily.

Other: placebo

Interventions

pomegranate juice DIETARY_SUPPLEMENT

Given orally daily.

Arm I

placebo OTHER

Given orally daily.

Arm II

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Must have completed prior surgery, cryotherapy, or radiotherapy for the primary tumor * Documented rising prostate-specific antigen (PSA) * Absolute level of PSA \> 0.2 ng/mL after surgery * Absolute level of PSA \> 1.0 ng/mL after radiation or cryotherapy * Absolute level of PSA ≥ 0.4 ng/mL after multiple treatment modalities (e.g., surgery with radiotherapy or radiotherapy with cryotherapy) * PSA must be ≥ 100% above best nadir achieved * PSA doubling time \> 3 months or ≤ 24 months * Patients must have ≥ 3 rising PSA time points above the minimum nadir achieved over ≥ 6 months * The interval between PSA time points must be \> 2 weeks * PSA ≤ 7.0 ng/mL * Patients who underwent radical prostatectomy and never achieved undetectable serum PSA after surgery are not eligible * Gleason score ≤ 7 * No histologically positive lymph nodes * No evidence of metastatic disease by physical examination, CT scan, or bone scan PATIENT CHARACTERISTICS: * Life expectancy ≥ 6 months * ECOG performance status 0 or 1 * No significant concomitant medical or psychiatric conditions that would limit study compliance * No known allergies to pomegranate extract * No known diabetes with hemoglobin A\_1c level \> 7.0% in the past 3 months * Diabetic patients entering study who have not had hemoglobin A\_1c level measured in the past 3 months must have levels measured at study initiation * No clinically abnormal laboratory values \> 2 times the upper limit of normal PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior and no concurrent experimental drugs, high-dose steroids, or other cancer treatment * No hormonal therapy, with the exception of neoadjuvant androgen-deprivation therapy (ADT), prior to or concurrent with primary therapy * Patients who received prior neoadjuvant ADT must have serum testosterone ≥ 150 ng/dL * No prior or concurrent hormonal therapy for rising PSA after primary therapy for prostate cancer * No finasteride or dutasteride at any time point after primary therapy and during study therapy * No other concurrent commercial pomegranate products * No other concurrent systemic or local therapy for prostate cancer * Concurrent dietary/herbal supplements (e.g., saw palmetto or selenium) allowed provided dose has been stable for ≥ 2 months prior to study entry and there are no plans to change or stop the supplements during study therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roll International Corporation: lead
• National Cancer Institute (NCI): collaborator

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

• Arie Belldegrun, MD, FACS

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 13, 2006
• First Posted: June 15, 2006
• Study Start: November 1, 2005
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 15, 2011

Record last verified: 2011-08