Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Hormone Sensitive Prostate Cancer
Metastatic Tumor
Lead sponsor: Santa Chiara Hospital
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 3000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Primary outcomes:
measure: progression free survival
timeFrame: 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
Secondary outcomes:
measure: overall survival
timeFrame: 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
Other outcomes:
measure: rate of patients with an objective response
timeFrame: through study completion, an average of 2 year
Locations:
city: Orbassano
country: Italy
facility: Azienda Ospedaliera San Luigi
state: Torino
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Trento
country: Italy
facility: Santa Chiara Hospital
Study officials:
References: