Status:
UNKNOWN
Radiation-hormone and Docetaxel VS Radiation-hormone in Patients With High-Risk Localized Prostate Cancer
Lead Sponsor:
Spanish Oncology Genito-Urinary Group
Collaborating Sponsors:
Pivotal S.L.
Conditions:
Prostate Cancer Stage III
Prostate Cancer Stage IV
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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...
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 Canc...
Eligibility Criteria
Inclusion
- Histological confirmation of adenocarcinoma of the prostate.
- Age \> 18 years.
- Localized high-risk prostate cancer, defined as:
- Stage III: T3 N0 M0, Gleason grade 8, 9, or 10, or
- Stage IV: T4 N0 M0, any Gleason grade or Tx N1 M0, any Gleason grade
- PSA \> 20 ng/mL.
- Karnofsky index ≥ 70%
- Good bone marrow reserve, with white blood cell count \> 3000/mm3, hemoglobin \>9.5 g/dL and platelets \> 150,000/mm3.
- Absence of hepatic abnormality, with bilirubin values \< 1.5 mg/dL and with SGOT/SGPT values up to 2 times the upper limit of normality for each site.
- Absence of abnormality in renal function, with creatinine levels up to 2 times the upper limit of normality for each site.
- Having given informed consent in writing.
Exclusion
- Previous hormone treatment during more than 3 months.
- Previous surgical treatment, pelvic radiation therapy, or chemotherapy for the current illness.
- Concomitant second neoplasm or history of neoplastic disease in the last 5 years, except for cutaneous basal cell carcinoma.
- Metabolic disease or uncontrolled systemic disease.
- Previous history of grade III-IV neuropathy (NCI CTCAE v3).
- Psychological, social, family, or geographical conditions that may compromise compliance with or follow-up of the study.
- Having received treatment with an investigational medicinal product during the 30 days prior to inclusion in the study.
- Inflammatory bowel disease.
Key Trial Info
Start Date :
December 18 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2023
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT03432780
Start Date
December 18 2008
End Date
November 14 2023
Last Update
January 22 2021
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