Evaluating treatment outcomes for hormone-sensitive metastatic prostate cancer
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
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 type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Sex | Male |
| Sponsor | Santa Chiara Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Orbassano, Torino and 2 other locations) |
| Trial ID | NCT06473259 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Orbassano, Torino and 2 other locations
- Azienda Ospedaliera San Luigi — Orbassano, Torino, Italy (Recruiting)
- Istituto Oncologico Veneto — Padova, Italy (Recruiting)
- Santa Chiara Hospital — Trento, Italy (Recruiting)
Study contacts
- Study coordinator: Orazio Caffo, MD
- Email: orazio.caffo@apss.tn.it
- Phone: +390461904416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.