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NCT Number: NCT06473259

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hormone Sensitive Prostate Cancer Male Urogenital Diseases Metastatic Tumor Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Primary location

Azienda Ospedaliera San Luigi, Orbassano, Torino, Italy

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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.
  • availability of inpatient and/or outpatient medical records for clinical data collection

Exclusion criteria

  • histological diagnosis other than adenocarcinoma
  • patients who have received multiple lines of ADT for mCSPC
  • patients who have received docetaxel or ARTA for metastatic castration-resistant disease

Treatment and study plan

docetaxel

Drug

6 courses of docetaxel 75 mg/sqm iv

Apalutamide Oral Tablet

Drug

240 mg /daily orally

Enzalutamide Oral Tablet

Drug

600 mg /daily orally

Abiraterone acetate tablets

Drug

1000 mg /daily orally

Darolutamide Oral Tablet

Drug

600 mg/daily orally

Radiotherapy

Radiation

radical radiotherapy on primary tumor

Triptorelin

Drug

3,75 mg im/4 w

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Orazio Caffo, MD

CONTACT

[email protected]

+390461904416

Sponsors and collaborators

Lead sponsor

Santa Chiara Hospital

Other

Registry information

Official study title

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

Acronym: ECHOS

Important dates

Study start
2016
Primary completion
2026
Study completion
2028
First posted
Jun 25, 2024
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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