Safety Study of Combination of Hormone Therapy, Paclitaxel and Radiation Therapy to Treat Prostate Cancer

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine if the combination therapy of Hormone, Paclitaxel and Radiation therapy are effective in treatment of locally advanced prostate cancer

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Albumin-Bound Paclitaxel; Hormones; Paclitaxel

Criteria

Inclusion Criteria:

• Any one or more of the following characteristics will qualify patient with T2/T3 prostate cancer for eligibility to current study:

• Biopsy proven prostate cancer with Gleason score > 7

• Pathologic staging TXN1 (on MRI or CT)

• Prostate-specific antigen (PSA) > 10 ng/ml done within a month prior to study entry (the day of first hormonal ablation) and > 10 days after prostate biopsy.

In addition patients must also have:

• Performance status < 2

• Hemoglobin > 11 grams per deciliter (g/dL), White blood cell (WBC) > 4000 and platelet count > 100.000/l

• No evidence of other synchronous primary. Prior malignancies does not exclude if the patient is disease free > 5 years.

• Prior or concurrent basal cell or non-invasive squamous carcinoma of the skin is eligible and

• Received hormone therapy with any of the following combination for less than 3 months

• Lupron / Flutamide

• Zoladex/ Flutamide

• Lupron/ Casodex

• Zoladex/ Casodex

Exclusion Criteria:

• Clinical stage T1N0, PSA < 10, and Gleason score less than 7.

• Evidence of distant metastasis

• Previous surgery for prostate cancer (radical prostatectomy).

• Current treatment with ketoconazole, cimetidine or hormone therapy for more than 3 months prior to inclusion in the protocol for prostate cancer

• Major medical or psychiatric illness, which in the investigator's opinion may prevent completion of the study and interfere with follow up.

• Bilirubin > 1.5

• Prior chemotherapy is not allowed