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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Notify MeKey information
Conditions
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
paclitaxel
DrugOther names: Abraxane
radiation therapy
RadiationPrimary outcomes
-
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)
-
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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