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Completed

NCT Number: NCT02911350

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hormone Suppressors

Drug

paclitaxel

Drug

Other names: Abraxane

radiation therapy

Radiation

Primary outcomes

  1. Maximum tolerated dose (MTD) assessment

    Time frame: 8 weeks

    The MTD will be the lowest dose at which 2/6 or 2/3 patients experience dose limiting toxicity (DLT)

  2. Number of participants with qualitative and quantitative toxicities

    Time frame: up to 8 months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2016
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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