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

Prostate Cancer Clinical Trial

Official title:

Phase I Study of Bi-weekly Taxol and Definitive Radiation in Androgen Ablated Locally Advanced Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911350
• Other study ID #: 9076
• Status: Completed
• Phase: Phase 1
• First received: August 29, 2016
• Last updated: September 28, 2017
• Start date: May 2000
• Est. completion date: December 2016

Study information

• Verified date: September 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Hormone Suppressors

• Paclitaxel

Radiation:
• Radiation Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

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