Herbal Therapy for Treatment of Recurrent Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00669656
First received: April 28, 2008
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

This study is about Prostate Health Cocktail, a combination supplement that contains vitamin D3, vitamin E, selenium, green tea extract, saw palmetto, lycopene, and soy derivatives. This product is currently available on the market, as herb and vitamin supplements are not regulated by the FDA. Each ingredient has been studied in prostate cancer cells and/or in patients with prostate cancer. At the doses included in this supplement, no serious side effects have been reported.

The purpose of this study is to find out whether Prostate Health Cocktail can lower your PSA. Additionally, we will be looking to see whether taking this treatment causes any unexpected side effects, and whether certain blood tests can inform us about your disease status in addition to your PSA


Condition Intervention Phase
Prostate Cancer
Drug: Prostate Health Cocktail
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of a Combination Herbal Therapy for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • The primary endpoint of this trial will be PSA response [ Time Frame: PSA measurement every 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity and side effects [ Time Frame: Assessed every 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: November 2008
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prostate Health Cocktail Drug: Prostate Health Cocktail
3 capsules daily PO up 12 months
Other Names:
  • Cholecalciferol
  • Vitamin D3
  • d-alpha tocopherol
  • vitamin E
  • L-selenomethionine
  • selenium
  • green tea extract
  • EGC
  • Epigallocatechin
  • saw palmetto
  • lycopene
  • Isoflavanoids
  • Daidzein
  • Genisetein

Detailed Description:

Objectives of this study are:

  • To assess the PSA response in prostate cancer patients who have a PSA-only disease recurrence after curative local therapy, during treatment with a combination herbal supplement.
  • To qualitatively and quantitatively describe the toxicity profile of this herbal supplement.
  • To assess changes in PSA doubling time for subjects treated with this supplement.
  • To measure tissue GRP78, serum neuroendocrine markers, and circulating tumor cells, for correlation with treatment response and prostate cancer outcomes
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria::

  • Age greater than or equal to 18
  • Histologically documented adenocarcinoma of the prostate
  • Initial treatment with radical prostatectomy or external beam radiation

    • Neoadjuvant/Adjuvant Androgen Deprivation therapy allowable, provided it was for a maximum of 24 months, with the last dose of medication at least 12 months previously
    • Neoadjuvant or adjuvant chemotherapy allowable, provided it was for a maximum of 6 months, with the last dose of medication at least 12 months previously
    • Adjuvant radiation after radical prostatectomy is allowed, provided at least 6 months have elapsed between completion of radiation and enrollment in study
  • PSA recurrence, with a rising PSA, as defined by:

    • Post Radiation Therapy:

      • Absolute PSA >2.0 ng/mL
      • PSA nadir <4 ng/mL after radiation
      • Absolute rise of at least 0.5 ng/mL total
      • At least 2 increases in PSA, separated by at least 2 weeks; these can be separated by a PSA value which declines provided the second rising value is higher than the first rising value.
    • Post Prostatectomy:

      • Absolute PSA >1.0 ng/mL
      • Absolute rise of at least 1 ng/mL total from nadir
      • At least 2 increases in PSA separated by at least 2 weeks; these can be separated by a PSA value which declines provided the second rising value is higher than the first value
  • PSA Doubling Time (PSA DT) more than 3 months and less than 36 months

    • PSA DT to be calculated using the web-based calculator at http://kevin.phys.unm.edu/psa/ with the following constraints:

      • At least 3 values, but no more than 6
      • All values must be >0.2
      • Values must be separated by at least 2 months
  • No radiographically evident bony or soft tissue metastases
  • Documented discussion between subject and physician about the option to pursue hormone therapy and/or salvage local therapy rather than enroll in this study
  • Patients who received treatment with androgen deprivation for biochemical recurrence are eligible provided:

    • They did not document castration resistance (defined as 2 rising PSA values while testosteron < 50
    • They have been off androgen deprivation for at least 3 months and have recovered their testosterone (>150)
    • They have decided,in conjunction with their treating physician that they do not want to resume androgen deprivation
  • ECOG Performance Status 0-2
  • Life expectancy > 12 months
  • Adequate hepatic function (AST, ALT, bilirubin <1.5 x ULN)
  • Adequate renal function (eGFR by Cockcroft-Gault or comparable calculation >50 ml/min)
  • Willing to discontinue all nutritional supplements and 5-alpha reductase inhibitors (finasteride, dutasteride) for the duration of study treatment, unless the medication is being used to control symptoms of BPH and the patient has been taking the medication for more than 6 weeks
  • Willing to discontinue all weight control medications for the duration of study treatment
  • Signed informed consent

Exclusion Criteria:

  • Atypical prostate carcinoma histology (ex: small cell, adenoid cystic)
  • Evidence of bony or soft tissue metastatic disease on CT/MRI or bone scan or PET/CT
  • Other invasive malignancy within prior 3 years, except for fully treated basal cell or squamous cell carcinoma of the skin.
  • Full-dose anticoagulation therapy (warfarin or low molecular weight heparin) or antiplatelet therapy (clopidogrel or ticlopidine), with the exception of low-dose aspirin therapy (81 mg).
  • Significant cardiac disease, included but not limited to angina, myocardial infarction, cardiomyopathy, congestive heart failure, and coronary artery disease which has required bypass surgery, angioplasty or stent placement.
  • Significant uncontrolled comorbid condition which, in the opinion of the treating physician would compromise the subject's ability to comply with protocol requirements, or would pose undue risk for experiencing adverse events.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669656

Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00669656     History of Changes
Other Study ID Numbers: 4P-07-3
Study First Received: April 28, 2008
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Cholecalciferol
Vitamin E
Tocopherols
Alpha-Tocopherol
Vitamins
Selenium
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements

ClinicalTrials.gov processed this record on August 25, 2014