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

January 20, 2021 updated by: Spanish Oncology Genito-Urinary Group

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)"

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docetaxel, hormone and radiation therapy
Radiation therapy combined with weekly docetaxel (20 mg/m2) and hormone therapy.
Drug: Docetaxel
Other Names:
  • Taxotere
Radiation: Radiation therapy
Biological: Hormone and radiation therapy
Active Comparator: Hormone and radiation therapy
Radiation therapy and hormone therapy
Radiation: Radiation therapy
Biological: Hormone and radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
5 years of randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
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
5 years
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.
5 years
Clinical response rate
Time Frame: 5 years
The clinical response rate: percentage of patients with partial and complete response, according to RECIST criteria.
5 years
Biochemical response rate.
Time Frame: 5 years
Biochemical response rate: percentage of patients with partial and complete response, according to PSA levels.
5 years
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
screening and week 9
Safety profile of the treatment.
Time Frame: 5 years
Numbers of events evaluated according to NCI criteria CTCAE v3
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Oncology Genito-Urinary Group

Collaborators

Pivotal S.L.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2008

Primary Completion (Anticipated)

November 14, 2023

Study Completion (Anticipated)

November 14, 2023

Study Registration Dates

First Submitted

January 15, 2018

First Submitted That Met QC Criteria

February 12, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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