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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02911350

Enrollment

Registered

2016-09-22

Start date

2000-05-31

Completion date

2016-12-31

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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

Interventions

DRUGHormone Suppressors

DRUGPaclitaxel

RADIATIONRadiation Therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026