CLINICAL TRIALS


Erythropoietin to Enhance Erection Recovery in Men Following Radical Prostatectomy


OVERVIEW

This study will evaluate the effectiveness of erythropoietin versus placebo in the recovery of erectile function in patients undergoing bilateral nerve-sparing radical retropubic prostatectomy for prostate cancer.

Recent laboratory findings suggest, that erythropoietin may play a role in protection of the cavernous nerves during surgery. Some degree of nerve trauma occurs during bilateral nerve-sparing radical prostatectomy, but for most it is temporary. Erythropoietin will be studied as an investigational drug for enhancement of erectile function postoperatively.


ELIGIBILITY

To be eligible for this study you must:

•Be between the ages of 40 and 59
•Have localized prostate cancer
•Be scheduled to have a bilateral nerve sparing radical prostatectomy at Johns Hopkins Hospital
•Have intact erectile function
•Have a sexual partner of at least 6 months


The length of the study is 12 months and involves receiving a dose of study drug or placebo on the day before surgery, the day of surgery, and the day following surgery. The study will also require the completion of questionnaires which will be mailed every three months until study completion.


PRINCIPAL INVESTIGATOR

Arthur L. Burnett, M.D.


CONTACT

Irene Trueheart, R.N.


Phone:(443) 287-1011
Email:itruehe1@jhmi.edu

Development and Evaluation of a Tumor Marker for Prostate Cancer


OVERVIEW

This study will be enrolling approximately 5000 patients interested in donating a blood sample. The populations that are eligible include patients experiencing an elevated PSA, a prostate biopsy or radical retropubic prostatectomy and scheduled to be seen in the Johns Hopkins Urology Clinic.


PRINCIPAL INVESTIGATOR

Alan Partin, M.D., Ph.D.


CONTACT

Leslie Mangold, MS


Phone:410-955-2139
Email:lmangold@jhmi.edu

Sequential administration of cryoablation and cyclophosphamide for advanced solid epithelial cancer


OVERVIEW

This research is being done to determine if the immune system can be stimulated to fight against advanced cancer when cryosurgery is combined with cyclophosphamide infusion, which is a certain form of chemotherapy. Both cryosurgery and cyclophosphamide chemotherapy are already currently in widespread use for the treatment of cancer. However, this is the first time this particular combination is being evaluated.


ELIGIBILITY

Patients with cancer who are not candidates for or are unwilling to undergo resection; anyone eligible for cryotherapy, but not expected to be cured by the cryotherapy alone. Eligible diagnoses include Renal cancer, Prostate cancer, Lung cancer,Breast cancer, Sarcoma, Colon cancer, Liver cancer, Pancreatic cancer, Bone cancer, Head & Neck cancer, Melanoma, Lymphoma, Carcinoma of unknown primary. Other criterias are:

    a) Age between 18 and 85
    b) ECOG* status of <2
    c) Patients must be capable of informed consent
    d) Life expectancy > 3 months
    e) Creatinine <2.5, platelets >75,000/mm3, INR<1.5
    f) Patients must be geographically accessible and willing to participate in all stages of treatment.
    (*ECOG: Eastern cooperative oncology group performance scale; <2 includes people who are fully ambulatory and are able to carry out light work)


PRINCIPAL INVESTIGATOR

Ronald Rodriguez, M.D., Ph.D.


CONTACT

Grace Lin, MSN, CRNP


Phone:(410) 502-5516
Email:glin5@jhmi.edu

Randomized, Controlled Phase II Study of Valproic Acid in Patients with Non-Metastatic Biochemical Progression of Prostate Cancer


OVERVIEW

This research is being done to find whether Valproic Acid, a U.S. Food and Drug Administration (FDA) approved medication for seizure and bipolar disorders, is effective in prostate cancer. In the laboratory, long-term administration of Valproic Acid (VPA) has been shown to slow the growth and increase death in prostate cancer cells in cellular and animal studies. This study aims to determine whether valproic acid can alter the kinetics of Prostate Specific Antigen (PSA) progression in patients with non-metastatic biochemical progression of prostate cancer.


ELIGIBILITY

If you are status post definitive local therapy (radical prostatectomy) for pathological proven prostate cancer and are asymptomatic with non-metastatic, biochemical progression (i.e. PSA recurrence) of prostate cancer along with following criteria, you are eligible for this trial. a) Age 18-85 years old. b) Minimum of three PSA values, each at least 4 weeks apart. The last PSA prior to study enrollment must be at least 1.0ng/ml and be rising over the prior value. c) Normal organ function as defined by: Total bilirubin within normal institutional limit; AST/ALT < 2.5 X institutional upper limit of normal; Creatinine < 2.5mg/dL; Platelet > 125,000 platelet/mm3. d) Participant is geographically accessible and is willing to participate in all stages of treatment


PRINCIPAL INVESTIGATOR

Ronald Rodriguez, M.D., Ph.D.


CONTACT

Grace Lin, MSN, CRNP


Phone:(410) 502-5516
Email:glin5@jhmi.edu

Supplementation Trial of Vitamin E in Prostate Cancer Patients (STEP)


OVERVIEW

Patients will be randomly assigned to take Vitamin E or placebo to determine if Vitamin E can change biological markers that may be important in causing prostate cancer.


ENROLLMENT

120


PRINCIPAL INVESTIGATOR

Drs. H. Ballentine Carter & HanYao Huang


The study of the natural history of patients with nonmetastatic prostate cancer with evidence of biochemical relapse following local treatment.


OVERVIEW

This is a descriptive study that will collect information related to disease status over time in an effort to define the natural history of prostate cancer, prognostic factors, and an algorithm for follow-up.


PRINCIPAL INVESTIGATOR

M.A. Eisenberger


Phone:(410) 955-8964



  
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