Trial 4P-07-3

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

Type: Cancer Therapy
Phase: Phase II
Status: Open to Accrual
Treatments: Other
Randomized: No
Defintions of terms and FAQ about clinical trials.

Trial Leaders/Researchers: Tanya Dorff, M.D.
Other Trial Staff: Charlean Ketchens, R.N., Lagrimas Ilagan, D.M., Ernesto Duverger, D.M.

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You may participate in this study if:

	Requirement
1	Men 18 y/o and above.
2	Histologically documented adenocarcinoma of the prostate.
3	Initial treatment with radical prostatectomy or external beam radiation.
4	Neoadjuvant / Adjuvant Androgen Deprivation therapy allowable, provided it was for a maximum of 9 months, with the last dose of medication at least 12 months previously.
5	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.
6	Adjuvant radiation after radical prostatectomy is allowed, provided at least 6 months have elapsed between completion of radiation and enrollment in study.
7	PSA recurrence, with a rising PSA, as defined by:
8	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, Two sequential increases in PSA, separated by at least 2 weeks.
9	Post Prostatectomy: absolute PSA >2.0 ng/mL, PSA nadir <0.3 after surgery, absolute rise of at least 2 ng/mL total, two sequential increases in PSA separated by at least 2 weeks.
10	PSA Doubling Time (PSA DT) more than 3 months and less than 18 months. PSA DT to be calculated using the web-based calculator at ttp://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.
11	No radiographically evident bony or soft tissue metastases.
12	Documented discussion between subject and physician about the option to pursue hormone therapy and/or salvage local therapy rather than enroll in this study.
13	ECOG Performance Status 0-2.
14	Life expectancy > 12 months.
15	Adequate hepatic function (AST, ALT & bilirubin less than or equal to 1.5 x ULN).
16	Adequate renal function (eGFR by Cockcroft-Gault or comparable calculation 50 ml/min or greater).
17	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.
18	Willing to discontinue all weight control medications for the duration of study treatment.
19	Signed Informed Consent, including HIPAA authorization.

You may not participate in this study if:

1	Atypical prostate carcinoma histology (ex: small cell, adenoid cystic).
2	Evidence of bony or soft tissue metastatic disease on CT or bone scan.
3	Prior treatment with androgen deprivation therapy for PSA recurrence, including GnRH analogue (leuprolide, goserelin) or anti-androgen (bicalutamide, flutamide, or nilutamide).
4	Other invasive malignancy within prior 3 years, except for fully treated basal cell or squamous cell carcinoma of the skin.
5	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).
6	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.
7	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.

For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.