Prostate CancerPhase 2NCT00669656
Herbal Therapy for Treatment of Recurrent Prostate Cancer
A Phase 2 study testing Prostate Health Cocktail in people with Prostate Cancer, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate Health Cocktail
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2008to 14 Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A Phase II Trial of a Combination Herbal Therapy for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy
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
Read the 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
- Conditions
- Prostate Cancer
- Being tested
- Prostate Health Cocktail
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Health CocktailDrug
Also called Cholecalciferol, Vitamin D3, d-alpha tocopherol, vitamin E
3 capsules daily PO up 12 months
| Study group | Role | What they receive |
|---|---|---|
| Prostate Health Cocktail | Experimental | Not described Receives: Drug: Prostate Health Cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this trial will be PSA response
Measured: PSA measurement every 4 weeks
Secondary outcomes (1)
Toxicity and side effects
Measured: Assessed every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study start6 Jul 2008
- Primary completion8 Jul 2014
- Study completion14 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanya Dorff, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669656
- Sponsor's protocol ID
- 4P-07-3
- Status last verified
- Apr 2017
- First submitted
- 28 Apr 2008
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of a Combination Herbal Therapy for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy
- ClinicalTrials.gov ID
- NCT00669656
- Acronym / sponsor ID
- 4P-07-3
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 6 Jul 2008 (actual)
- Primary completion
- 8 Jul 2014 (actual)
- Study completion
- 14 Oct 2014 (actual)
- First posted
- 30 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Health Cocktail | Experimental | Drug: Prostate Health Cocktail |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Age greater than or equal to 18
- Histologically documented adenocarcinoma of the prostate
- Initial treatment with radical prostatectomy or external beam radiation
- PSA recurrence, with a rising PSA, as defined by:
- PSA Doubling Time (PSA DT) more than 3 months and less than 36 months
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate Health CocktailAlso: Cholecalciferol, Vitamin D3, d-alpha tocopherol, vitamin E3 capsules daily PO up 12 months | Drug | Prostate Health Cocktail |
Primary outcome
The primary endpoint of this trial will be PSA response
Time frame: PSA measurement every 4 weeks
1 secondary outcome
Toxicity and side effects
Time frame: Assessed every 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Dorff, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prostate Health Cocktail in people with Prostate Cancer, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this trial will be PSA response (time frame: PSA measurement every 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.