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

NCT06473259 | Recruiting

• 1 other identifier: A349
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 3

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

Conditions

Prostate Cancer; Hormone Sensitive Prostate Cancer; Metastatic Tumor

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• overall survival

  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

  through study completion, an average of 2 year

Study Arms (4)

ADT + docetaxel

mHSPC patients treated with ADT + docetaxel

Drug: Docetaxel; Drug: Triptorelin

ADT + ARPI

mHSPC patients treated with ADT + ARPI

Drug: Apalutamide Oral Tablet; Drug: Enzalutamide Oral Tablet; Drug: Abiraterone acetate tablets; Drug: Triptorelin

ADT + ARPI + docetaxel

mHSPC patients treated with ADT + docetaxel + ARPI

Drug: Docetaxel; Drug: Darolutamide Oral Tablet; Drug: Triptorelin

ADT + radiotherapy on primary tumor

mHSPC patients treated with ADT + radiotherapy on primary tumor

Radiation: radiotherapy; Drug: Triptorelin

Interventions

Docetaxel DRUG

6 courses of docetaxel 75 mg/sqm iv

ADT + ARPI + docetaxel; ADT + docetaxel

Apalutamide Oral Tablet DRUG

240 mg /daily orally

ADT + ARPI

Enzalutamide Oral Tablet DRUG

600 mg /daily orally

ADT + ARPI

Abiraterone acetate tablets DRUG

1000 mg /daily orally

ADT + ARPI

Darolutamide Oral Tablet DRUG

600 mg/daily orally

ADT + ARPI + docetaxel

radiotherapy RADIATION

radical radiotherapy on primary tumor

ADT + radiotherapy on primary tumor

Triptorelin DRUG

3,75 mg im/4 w

ADT + ARPI; ADT + ARPI + docetaxel; ADT + docetaxel; ADT + radiotherapy on primary tumor

Eligibility Criteria

• Sex: male
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Santa Chiara Hospital: lead

Study Sites (3)

Azienda Ospedaliera San Luigi

Orbassano, Torino, 10043, Italy

RECRUITING

Istituto Oncologico Veneto

Padua, 35128, Italy

RECRUITING

Santa Chiara Hospital

Trento, 38122, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Docetaxel; apalutamide; enzalutamide; Abiraterone Acetate; darolutamide; Radiotherapy; Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Therapeutics; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Orazio Caffo, MD

CONTACT

+390461904416; orazio.caffo@apss.tn.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 25, 2024
• Study Start: December 16, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

IT (3)