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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

ConditionsProstate CancerHormone Sensitive Prostate CancerMetastatic Tumor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorSanta Chiara Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Docetaxel

    Drug

    6 courses of docetaxel 75 mg/sqm iv

  • 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

Treatment groups

3,000 Participants
are divided into 4 treatment groups
Group A: ADT + docetaxel2 interventions
Group B: ADT + ARPI4 interventions
Group C: ADT + ARPI + docetaxel3 interventions
Group D: ADT + radiotherapy on primary tumor2 interventions

Trial outcomes

Primary outcomes

1

progression free survival

the projected rate over the time of patients without progressive disease

Time frame
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

1

overall survival

the projected rate over the time of alive patients

Time frame
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

1

rate of patients with an objective response

rate of patients who experienced a reduction of at least 30% of measurable lesions

Time frame
through study completion, an average of 2 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Santa Chiara Hospital

Lead sponsor

Source ClinicalTrials.gov
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