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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Hormone Suppressors; Drug: Paclitaxel; Radiation: Radiation Therapy

• Registration Number: NCT02911350
• Lead Sponsor: NYU Langone Health

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hormone Suppressors, Paclitaxel & Radiation therapy	Hormone Suppressors	Hormone Suppressors: Patients may take any of the following combinations for a period of 6 months: 1. Lupron / Flutamide 2. Zoladex/ Flutamide 3. Lupron/ Casodex 4. Zoladex/ Casodex Paclitaxel: 30 mg/m2 twice a week administered as a one hour infusion either Monday \& Wednesday or Tuesday \& Thursday for eight consecutive weeks will be started within the first week of radiation therapy. Following the first 3 dose levels, the dose of Paclitaxel will be escalated to 35 mg/m2 (dose level IV), 40 mg/m2 (dose level V) \& 45 mg/m2 (dose level VI). Radiation Therapy: 5 days a week for 8 weeks to a total dose of 66.6 to 73.8 Gray depending on when patient enter the study.
Hormone Suppressors, Paclitaxel & Radiation therapy	Paclitaxel	Hormone Suppressors: Patients may take any of the following combinations for a period of 6 months: 1. Lupron / Flutamide 2. Zoladex/ Flutamide 3. Lupron/ Casodex 4. Zoladex/ Casodex Paclitaxel: 30 mg/m2 twice a week administered as a one hour infusion either Monday \& Wednesday or Tuesday \& Thursday for eight consecutive weeks will be started within the first week of radiation therapy. Following the first 3 dose levels, the dose of Paclitaxel will be escalated to 35 mg/m2 (dose level IV), 40 mg/m2 (dose level V) \& 45 mg/m2 (dose level VI). Radiation Therapy: 5 days a week for 8 weeks to a total dose of 66.6 to 73.8 Gray depending on when patient enter the study.
Hormone Suppressors, Paclitaxel & Radiation therapy	Radiation Therapy	Hormone Suppressors: Patients may take any of the following combinations for a period of 6 months: 1. Lupron / Flutamide 2. Zoladex/ Flutamide 3. Lupron/ Casodex 4. Zoladex/ Casodex Paclitaxel: 30 mg/m2 twice a week administered as a one hour infusion either Monday \& Wednesday or Tuesday \& Thursday for eight consecutive weeks will be started within the first week of radiation therapy. Following the first 3 dose levels, the dose of Paclitaxel will be escalated to 35 mg/m2 (dose level IV), 40 mg/m2 (dose level V) \& 45 mg/m2 (dose level VI). Radiation Therapy: 5 days a week for 8 weeks to a total dose of 66.6 to 73.8 Gray depending on when patient enter the study.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) assessment	8 weeks	The MTD will be the lowest dose at which 2/6 or 2/3 patients experience dose limiting toxicity (DLT)
Number of participants with qualitative and quantitative toxicities	up to 8 months