Radiation-hormone and Docetaxel VS Radiation-hormone in Patients With High-Risk Localized Prostate Cancer (QRT-SOGUG)

S

Spanish Oncology Genito-Urinary Group

Status and phase

Active, not recruiting
Phase 2

Conditions

Prostate Cancer Stage IV
Prostate Cancer Stage III

Treatments

Radiation: Radiation therapy
Drug: Docetaxel
Biological: Hormone and radiation therapy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03432780
2008-003554-14 (EudraCT Number)
QRT-SOGUG

Details and patient eligibility

About

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.

Full 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.

Enrollment

134 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

134 participants in 2 patient groups

Docetaxel, hormone and radiation therapy
Experimental group
Description:
Radiation therapy combined with weekly docetaxel (20 mg/m2) and hormone therapy.
Treatment:
Biological: Hormone and radiation therapy
Drug: Docetaxel
Radiation: Radiation therapy
Hormone and radiation therapy
Active Comparator group
Description:
Radiation therapy and hormone therapy
Treatment:
Biological: Hormone and radiation therapy
Radiation: Radiation therapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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