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Recruiting NCT06473259

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

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Clinical Trial Summary
NCT ID NCT06473259
Status Recruiting
Phase
Sponsor Santa Chiara Hospital
Condition Prostate Cancer
Study Type OBSERVATIONAL
Enrollment 3,000 participants
Start Date 2016-12-16
Primary Completion 2026-12

Eligibility & Interventions

Sex Male only
Min Age N/A
Max Age N/A
Study Type OBSERVATIONAL
Interventions
DocetaxelApalutamide Oral TabletEnzalutamide Oral Tablet

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 3,000 participants in total. It began in 2016-12-16 with a primary completion date of 2026-12.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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

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

Contact & Investigator

Central Contact

Orazio Caffo, MD

✉ orazio.caffo@apss.tn.it

📞 +390461904416

Frequently Asked Questions

Who can join the NCT06473259 clinical trial?

This trial is open to male participants only, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06473259 currently recruiting?

Yes, NCT06473259 is actively recruiting participants. Contact the research team at orazio.caffo@apss.tn.it for enrollment information.

Where is the NCT06473259 trial being conducted?

This trial is being conducted at Orbassano, Italy, Padova, Italy, Trento, Italy.

Who is sponsoring the NCT06473259 clinical trial?

NCT06473259 is sponsored by Santa Chiara Hospital. The trial plans to enroll 3,000 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology