Clinical trial Recruiting at 3 sites Observational Men only

Evaluating treatment outcomes for hormone-sensitive metastatic prostate cancer

Official 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

Run by Santa Chiara Hospital · NCT06473259 · Data updated 2026-11-12

This study looks at how well different treatments work for men with hormone-sensitive metastatic prostate cancer who have just started hormone therapy.

Quick facts

Study typeObservational
SexMen only
Enrollment3000 (estimated)
SponsorSanta Chiara Hospital
Academic / other
Drugs / interventionsradiation
Locations3 sites (Orbassano, Torino and 2 other locations)
StatusRecruiting
StartedDecember 16, 2016
Main results expectedDecember 2026
Study endsDecember 2028
Registry record updatedJune 25, 2024
Trial IDNCT06473259 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are men with a histologically confirmed diagnosis of adenocarcinoma of the prostate who are newly diagnosed with metastatic disease and have not undergone previous treatment except for recent hormone therapy.

Probably not a fit

Patients with histological diagnoses other than adenocarcinoma or those who have received multiple lines of androgen deprivation therapy for metastatic castration-sensitive prostate cancer may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the clinical outcomes of various treatments, including docetaxel and androgen-receptor targeting agents, either alone or in combination with radiotherapy, for patients with hormone-sensitive metastatic prostate cancer. The study will analyze data from an unselected population receiving these treatments in routine clinical practice. It will focus on patients who have recently initiated hormone therapy and will collect clinical data from their medical records to evaluate treatment effectiveness.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective treatment strategies for hormone-sensitive metastatic prostate cancer, potentially improving patient outcomes.

How similar studies have gone: Other studies have explored similar treatment approaches for metastatic prostate cancer, indicating potential for success, but this specific combination and observational methodology may offer novel insights.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Azienda Ospedaliera San Luigi
    Orbassano, Torino, Italy
    Recruiting
  • Istituto Oncologico Veneto
    Padova, Italy
    Recruiting
  • Santa Chiara Hospital
    Trento, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.