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

Launched by SANTA CHIARA HOSPITAL · Jun 24, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how different treatments work for men with hormone-sensitive metastatic prostate cancer, which means the cancer has spread but still responds to hormone therapy. Researchers want to see the effects of various treatments, such as chemotherapy, a targeted therapy for the androgen receptor, and radiotherapy, either on their own or in combination with hormone therapy. The aim is to understand how these treatments perform in real-world settings, as the study gathers information from patients being treated in hospitals or clinics across a specific time period.

To be eligible for this study, participants need to have a confirmed diagnosis of metastatic prostate cancer that hasn't been treated with anything other than hormone therapy in the last 4-6 months. They should also be starting one of the specified treatments, like docetaxel or targeted therapy, between January 2015 and December 2027. Participants can expect to have their clinical data collected from their medical records, which will help researchers evaluate how well these treatments work in practice. This study is currently recruiting and aims to gather valuable information that could improve future treatment options for men with this condition.

Gender

MALE

Eligibility criteria

• 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