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
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
About This Trial
- This study looks at how well common treatments—such as chemotherapy, advanced hormone pills, and radiation—work when added to standard hormone therapy for men whose prostate cancer has spread to other parts of the body.
- It is open to patients with advanced prostate cancer that still responds to hormone-lowering treatments and who have not received multiple prior therapies.
- Before considering this study, you should know that it is observational, meaning doctors will not give you an experimental drug, but will instead track your health records while you receive your normal medical care.
More Information
- 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
Who Can Enroll
- Gender: Male
- Who This Trial is For: This study looks at how well common treatments—such as chemotherapy, advanced hormone pills, and radiation—work when added to standard hormone therapy for men whose prostate cancer has spread to other parts of the body.
Study Details
- Start Date: December 16, 2016
- Lead Sponsor: Santa Chiara Hospital
Full Eligibility Criteria
Inclusion Criteria
- 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
- 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.
- availability of inpatient and/or outpatient medical records for clinical data collection
Exclusion Criteria
- histological diagnosis other than adenocarcinoma
- patients who have received multiple lines of ADT for mCSPC
- patients who have received docetaxel or ARTA for metastatic castration-resistant disease
Treatments
- Drug: Docetaxel
- Drug: Apalutamide Oral Tablet
- Drug: Enzalutamide Oral Tablet
- Drug: Abiraterone acetate tablets
- Drug: Darolutamide Oral Tablet
- Radiation: radiotherapy
- Drug: Triptorelin