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Efficacy Study Evaluating Chemotherapy in Prostate Cancer

NCT01978873 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2016-05-04

No results posted yet for this study

Summary

This clinical trial is designed on the basis of an unmet clinical need, as well as other factors including: 1) the ability to identify subjects at high risk of dying early from their disease, 2) the fact that hormonal therapy has already been shown to improve survival when applied early in the natural history, 3) the availability of chemotherapy such as cabazitaxel that can improve survival in subjects with advanced disease and 4) that chemotherapy (docetaxel) given concomitant with hormone treatment has proven to prolong time to progression.

It is the investigators hypothesis that a more appropriate group of patients who may benefit from the curative potential of systemic chemo-hormonal modality is that with minimal, but detectable disease who have a high probability of developing metastatic disease, clinical symptoms and eventually death from prostate cancer in a defined time frame. The investigators hypothesize further that the approach is likely to be more effective at a time of minimal tumour burden, resulting in minimization of the overall burden of therapy and better quality of life while on treatment.

This trial will determine whether any benefit is gained by adding chemotherapy before hormonal therapy to hormonal therapy alone in the population of subjects with metastatic or high risk disease.

Conditions

Interventions

DRUG

Cabazitaxel + Androgen deprivation therapy

Cabazitaxel + LHRH agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device.

DRUG

Androgen deprivation therapy

LHRH agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device.

Sponsors & Collaborators

  • Örebro University, Sweden

    lead OTHER

Principal Investigators

  • Ove Andrén, Ass Prof. · University Hospital Örebro

  • Marie Hjelm-Eriksson, MD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2018-11-30
Completion
2019-11-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01978873 on ClinicalTrials.gov