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 type | Observational |
|---|---|
| Sex | Men only |
| Enrollment | 3000 (estimated) |
| Sponsor | Santa Chiara Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Orbassano, Torino and 2 other locations) |
| Status | Recruiting |
| Started | December 16, 2016 |
| Main results expected | December 2026 |
| Study ends | December 2028 |
| Registry record updated | June 25, 2024 |
| Trial ID | NCT06473259 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
- Study coordinator: Orazio Caffo, MD
- Email: orazio.caffo@apss.tn.it
- Phone: +390461904416
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Mevrometostat plus enzalutamide versus enzalutamide alone for men with metastatic castration‑sensitive prostate cancer who are ARPI‑naïve
This trial will test whether adding the investigational drug mevrometostat to enzalutamide helps men with metastatic castration‑sensitive prostate cancer who have not received androgen receptor pathway inhibitors or chemotherapy.
-
Radiation therapy for recurrent prostate cancer
This study is testing a new way to use radiation therapy for men with recurrent prostate cancer to see if it helps control the cancer better while also keeping their quality of life intact.
-
Treatment for recurrent prostate cancer with metastases
This study is testing whether combining hormone therapy with targeted radiation or surgery can help men with recurrent prostate cancer live longer without their cancer spreading.
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Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519
This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.
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PSMA-guided surgery and tissue-resident T cells in node-positive prostate cancer
This study tests whether PSMA-guided surgery can help identify and study tissue-resident T cells in prostate cancer that has spread to lymph nodes.
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Predictive factors for response to Lu-177 PSMA therapy in metastatic castration-resistant prostate cancer
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.