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
NCT ID: NCT06473259
Last Updated: 2024-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2016-12-16
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ADT + docetaxel
mHSPC patients treated with ADT + docetaxel
Docetaxel
6 courses of docetaxel 75 mg/sqm iv
Triptorelin
3,75 mg im/4 w
ADT + ARPI
mHSPC patients treated with ADT + ARPI
Apalutamide Oral Tablet
240 mg /daily orally
Enzalutamide Oral Tablet
600 mg /daily orally
Abiraterone acetate tablets
1000 mg /daily orally
Triptorelin
3,75 mg im/4 w
ADT + ARPI + docetaxel
mHSPC patients treated with ADT + docetaxel + ARPI
Docetaxel
6 courses of docetaxel 75 mg/sqm iv
Darolutamide Oral Tablet
600 mg/daily orally
Triptorelin
3,75 mg im/4 w
ADT + radiotherapy on primary tumor
mHSPC patients treated with ADT + radiotherapy on primary tumor
radiotherapy
radical radiotherapy on primary tumor
Triptorelin
3,75 mg im/4 w
Interventions
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Docetaxel
6 courses of docetaxel 75 mg/sqm iv
Apalutamide Oral Tablet
240 mg /daily orally
Enzalutamide Oral Tablet
600 mg /daily orally
Abiraterone acetate tablets
1000 mg /daily orally
Darolutamide Oral Tablet
600 mg/daily orally
radiotherapy
radical radiotherapy on primary tumor
Triptorelin
3,75 mg im/4 w
Eligibility Criteria
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Inclusion Criteria
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
2. patients who have received multiple lines of ADT for mCSPC
3. patients who have received docetaxel or ARTA for metastatic castration-resistant disease
MALE
No
Sponsors
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Santa Chiara Hospital
OTHER
Responsible Party
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Orazio Caffo
Director
Locations
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Azienda Ospedaliera San Luigi
Orbassano, Torino, Italy
Istituto Oncologico Veneto
Padua, , Italy
Santa Chiara Hospital
Trento, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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A349
Identifier Type: -
Identifier Source: org_study_id
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