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A Phase II Trial of a Combination Herbal Therapy for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Phase II Trial of a Combination Herbal Therapy for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy


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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint of this trial will be PSA response

Outcome Time Frame:

PSA measurement every 4 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

4P-07-3

NCT ID:

NCT00669656

Start Date:

November 2008

Completion Date:

July 2015

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800