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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03432780
Recruitment Status : Active, not recruiting
First Posted : February 14, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Pivotal S.L.
Information provided by (Responsible Party):
Spanish Oncology Genito-Urinary Group

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 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Stage III Prostate Cancer Stage IV Drug: Docetaxel Biological: Hormone and radiation therapy Radiation: Radiation therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, multicenter, multidisciplinary, parallel-group, open-label study with randomized group assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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)"
Actual Study Start Date : December 18, 2008
Estimated Primary Completion Date : November 14, 2023
Estimated Study Completion Date : November 14, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Docetaxel, hormone and radiation therapy
Radiation therapy combined with weekly docetaxel (20 mg/m2) and hormone therapy.
Drug: Docetaxel
Other Name: Taxotere

Biological: Hormone and radiation therapy
Radiation: Radiation therapy
Active Comparator: Hormone and radiation therapy
Radiation therapy and hormone therapy
Biological: Hormone and radiation therapy
Radiation: Radiation therapy



Primary Outcome Measures :
  1. 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 [ Time Frame: 5 years of randomization ]
    Percentage of patients free of elevation of PSA by 2 ng/mL above the minimum level reached since treatment (biochemical reccurrence), calculating the at-call event, i.e., the date of last confirmatory test (Phoenix criteria).


Secondary Outcome Measures :
  1. Percentage of patients with biochemical recurrence-free survival [ Time Frame: 5 years ]
    The duration of survival, in months, between randomization of the patient in the study and the date of recurrence by PSA. In the remaining patients, the last available follow-up will be taken as the last control

  2. Percentage of patients with progression-free survival [ Time Frame: 5 years ]
    The duration of survival, in months, between randomization of the patient in the study and the date of recurrence by PSA, clinical manifestations or death due to disease. In the remaining patients, the last available follow-up will be taken as the last control

  3. Percentage of patients with overall survival. [ Time Frame: 5 years ]
    Defined as the time that elapses, in months, between randomization of the patient in the study and the date of death, regardless of the cause. In the remaining patients, the last available follow-up will be taken as the last control.

  4. Clinical response rate [ Time Frame: 5 years ]
    The clinical response rate: percentage of patients with partial and complete response, according to RECIST criteria.

  5. Biochemical response rate. [ Time Frame: 5 years ]
    Biochemical response rate: percentage of patients with partial and complete response, according to PSA levels.

  6. Quality of life of the patients [ Time Frame: screening and week 9 ]
    Change from baseline in the Quality of Life Questionnaire C30 scale (QLQ-C30) to week 9. The QLQ-c30 has five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. They are assigned values between 1 and 4 (1: nothing, 2: a few, 3: enough, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with a score from 1 to 7 (1: terrible, 7: excellent). The obtained scores are summed and standardized and gets a score between 0 and 100

  7. Safety profile of the treatment. [ Time Frame: 5 years ]
    Numbers of events evaluated according to NCI criteria CTCAE v3



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   prostate cancer is present only in male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological confirmation of adenocarcinoma of the prostate.
  2. Age > 18 years.
  3. 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
  4. PSA > 20 ng/mL.
  5. Karnofsky index ≥ 70%
  6. Good bone marrow reserve, with white blood cell count > 3000/mm3, hemoglobin >9.5 g/dL and platelets > 150,000/mm3.
  7. 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.
  8. Absence of abnormality in renal function, with creatinine levels up to 2 times the upper limit of normality for each site.
  9. Having given informed consent in writing.

Exclusion Criteria:

  1. Previous hormone treatment during more than 3 months.
  2. Previous surgical treatment, pelvic radiation therapy, or chemotherapy for the current illness.
  3. Concomitant second neoplasm or history of neoplastic disease in the last 5 years, except for cutaneous basal cell carcinoma.
  4. Metabolic disease or uncontrolled systemic disease.
  5. Previous history of grade III-IV neuropathy (NCI CTCAE v3).
  6. Psychological, social, family, or geographical conditions that may compromise compliance with or follow-up of the study.
  7. Having received treatment with an investigational medicinal product during the 30 days prior to inclusion in the study.
  8. Inflammatory bowel disease.

Additional Information:
Publications of Results:

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Responsible Party: Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier: NCT03432780    
Other Study ID Numbers: QRT-SOGUG
2008-003554-14 ( EudraCT Number )
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Docetaxel
Hormones
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs