Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients (ECHOS)

June 24, 2024 updated by: Orazio Caffo, Santa Chiara Hospital

Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Therapy (Alone or in Combination) or Radiotherapy on the Primary Tumor in Combination With Androgen Deprivation Therapy in Metastatic Hormone-sensitive Prostate Cancer: Multicenter Observational Study of Patients Undergoing Treatment in Clinical Practice in Italian Hospitals

The aim of this observational study is to evaluate the clinical outcomes of treatment with docetaxel, ARTA (alone or in combination) or with radiotherapy on the primary tumor for mCSPC, in an unselected population, in clinical practice

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto
        • Contact:
        • Principal Investigator:
          • Basso Umberto
      • Trento, Italy, 38122
        • Recruiting
        • Santa Chiara Hospital
        • Principal Investigator:
          • Orazio Caffo
        • Contact:
    • Torino
      • Orbassano, Torino, Italy, 10043
        • Recruiting
        • Azienda Ospedaliera San Luigi
        • Contact:
        • Principal Investigator:
          • Consuelo Buttigliero, MD, PhD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients with mCSPC who initiated treatment with docetaxel, ARPI (alone or in combination) or with radiotherapy on the primary tumor in addition to ADT within clinical practice or expanded access programs in Italian hospitals from January 2015 to December 2027 will be studied.

Description

Inclusion Criteria:

  1. histologically confirmed diagnosis of adenocarcinoma of the prostate, metastatic, not undergoing previous treatment (except hormone therapy initiated no more than 4-6 months prior to docetaxel) for metastatic disease
  2. treatment with docetaxel, ARPI (alone or in combination) or with radiation therapy on the primary tumor in combination with ADT within normal clinical practice or expanded access programs initiated between January 2015 and December 2027.
  3. availability of inpatient and/or outpatient medical records for clinical data collection

Exclusion Criteria:

  1. histological diagnosis other than adenocarcinoma
  2. patients who have received multiple lines of ADT for mCSPC
  3. patients who have received docetaxel or ARTA for metastatic castration-resistant 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ADT + docetaxel
mHSPC patients treated with ADT + docetaxel
Drug: Docetaxel
6 courses of docetaxel 75 mg/sqm iv
Drug: Triptorelin
3,75 mg im/4 w
ADT + ARPI
mHSPC patients treated with ADT + ARPI
Drug: Triptorelin
3,75 mg im/4 w
Drug: Apalutamide Oral Tablet
240 mg /daily orally
Drug: Enzalutamide Oral Tablet
600 mg /daily orally
Drug: Abiraterone acetate tablets
1000 mg /daily orally
ADT + ARPI + docetaxel
mHSPC patients treated with ADT + docetaxel + ARPI
Drug: Docetaxel
6 courses of docetaxel 75 mg/sqm iv
Drug: Triptorelin
3,75 mg im/4 w
Drug: Darolutamide Oral Tablet
600 mg/daily orally
ADT + radiotherapy on primary tumor
mHSPC patients treated with ADT + radiotherapy on primary tumor
Drug: Triptorelin
3,75 mg im/4 w
Radiation: radiotherapy
radical radiotherapy on primary tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
the projected rate over the time of patients without progressive disease
From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
the projected rate over the time of alive patients
From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of patients with an objective response
Time Frame: through study completion, an average of 2 year
rate of patients who experienced a reduction of at least 30% of measurable lesions
through study completion, an average of 2 year

Collaborators and Investigators

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

Sponsor

Santa Chiara Hospital

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 16, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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