Trials / Unknown
UnknownNCT03432780
Radiation-hormone and Docetaxel VS Radiation-hormone in Patients With High-Risk Localized Prostate Cancer
Randomized Phase II Clinical Study of Radiation Therapy, Hormone Therapy and Chemotherapy With Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients With High-Risk Localized Prostate Cancer (Stage III and IV)"
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- Spanish Oncology Genito-Urinary Group · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, multicenter, parallel-group, open-label, randomized, phase II Clinical Study of Radiation Therapy, Hormone Therapy and Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) whose primary objective is determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis.
Detailed description
Randomized Phase II Clinical Study of Radiation Therapy, Hormone Therapy and Chemotherapy with Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) Primary Objective: To determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis. Design: A prospective, multicenter, multidisciplinary, parallel-group, open-label study with randomized group assignment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Docetaxel | |
| BIOLOGICAL | Hormone and radiation therapy | |
| RADIATION | Radiation therapy |
Timeline
- Start date
- 2008-12-18
- Primary completion
- 2023-11-14
- Completion
- 2023-11-14
- First posted
- 2018-02-14
- Last updated
- 2021-01-22
Source: ClinicalTrials.gov record NCT03432780. Inclusion in this directory is not an endorsement.