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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADT + docetaxel | mHSPC patients treated with ADT + docetaxel |
| |
| ADT + ARPI | mHSPC patients treated with ADT + ARPI |
| |
| ADT + ARPI + docetaxel | mHSPC patients treated with ADT + docetaxel + ARPI |
| |
| ADT + radiotherapy on primary tumor | mHSPC patients treated with ADT + radiotherapy on primary tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 6 courses of docetaxel 75 mg/sqm iv |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | the projected rate over the time of patients without progressive disease | From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | the projected rate over the time of alive patients | From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months |
| Measure | Description | Time Frame |
|---|---|---|
| rate of patients with an objective response | rate of patients who experienced a reduction of at least 30% of measurable lesions | through study completion, an average of 2 year |
Inclusion Criteria:
Exclusion Criteria:
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All patients with mCSPC who initiated treatment with docetaxel, ARPI (alone or in combination) or with radiotherapy on the primary tumor in addition to ADT within clinical practice or expanded access programs in Italian hospitals from January 2015 to December 2027 will be studied.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Orazio Caffo, MD | Contact | +390461904416 | orazio.caffo@apss.tn.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera San Luigi | Recruiting | Orbassano | Torino | 10043 | Italy |
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| Apalutamide Oral Tablet | Drug | 240 mg /daily orally |
|
| Enzalutamide Oral Tablet | Drug | 600 mg /daily orally |
|
| Abiraterone acetate tablets | Drug | 1000 mg /daily orally |
|
| Darolutamide Oral Tablet | Drug | 600 mg/daily orally |
|
| radiotherapy | Radiation | radical radiotherapy on primary tumor |
|
| Triptorelin | Drug | 3,75 mg im/4 w |
|
| Istituto Oncologico Veneto | Recruiting | Padova | 35128 | Italy |
|
| Santa Chiara Hospital | Recruiting | Trento | 38122 | Italy |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C572045 | apalutamide |
| C540278 | enzalutamide |
| D000069501 | Abiraterone Acetate |
| C000607739 | darolutamide |
| D011878 | Radiotherapy |
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013812 | Therapeutics |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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