An Observational Study to Learn More About Treatment Patterns and Factors Determining the Choice of Treatment in Canadian Men With Metastatic Hormone Sensitive Prostate Cancer in Routine Medical Care (RE-ENGAGE)

Bayer

Status: Active, not recruiting

Conditions: Metastatic Hormone-sensitive Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT06874114

22917

Details and patient eligibility

About

This is an observational study in which only data are collected from adult Canadian men with metastatic hormone sensitive prostate cancer (mHSPC) are studied. Participants will not receive any advice on treatment or any changes to the healthcare.

Metastatic hormone sensitive prostate cancer is a cancer of the prostate gland, a male reproductive gland found below the bladder. Metastatic means that cancer has spread to other parts of the body. Hormone-sensitive means it can be treated with anti-hormonal therapy such as androgen deprivation therapy (ADT).

ADT lowers the level of testosterone and slows down the growth of cancer cells. However, in some cases, ADT alone is not sufficient and doctors recommend combining it with treatments like Androgen Receptor Pathway Inhibitors (ARPi) and/or docetaxel to stop the growth of cancer cells.

ARPi slow down the growth of the cancer cells by blocking a sex hormone called the androgens from attaching to the protein found in the cancer cells. ARPi includes medicines like apalutamide, darolutamide, and enzalutamide.

Docetaxel is a medicine used to treat different types of cancer and works by stopping the growth and spread of cancer cells. ADT, ARPi, and docetaxel are approved treatments for men with mHSPC in Canada.

The participants in this study are already receiving treatment for mHSPC as part of their routine medical care from their doctors.

Enrollment: 700 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men aged ≥ 18 years diagnosed with mHSPC verified by radiographic evidence of metastasis with Conventional Imaging (CI) or Prostate Specific Membrane Antigen-Positron Emission Tomography (PSMA-PET), and histologically confirmed carcinoma
• At least 6 months follow-up post-diagnosis period, unless the patient died earlier

Exclusion criteria

• ADT use for >6 months or any use of ARPi (ADT use in the neoadjuvant or adjuvant setting where the patient has been off treatment for 12 months or more is allowed)
• This criterion is to ensure that we are capturing mHSPC patients and not Metastatic Castration-Resistant Prostate Cancer (mCRPC) patients who have progressed from earlier stages
• Evidence of inclusion in clinical trials during the study period

Trial design

700 participants in 5 patient groups

Cohort A

Description:

No Androgen Deprivation Therapy (ADT) nor Androgen Receptor Pathway Inhibitor (ARPi) treatment

Cohort B

Description:

Androgen Deprivation Therapy (ADT) Monotherapy: Patients initiating or continuing ADT alone for up to 180 days after Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) diagnosis

Cohort C

Description:

Androgen Deprivation Therapy (ADT)+Docetaxel: Patients initiating docetaxel within 180 days of start of ADT after Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) diagnosis

Cohort D

Description:

Androgen Deprivation Therapy (ADT)+Androgen Receptor Pathway Inhibitor (ARPi): Patients initiating ARPi within 180 days of start of ADT after mHSPC diagnosis

Cohort E

Description:

Androgen Deprivation Therapy (ADT)+Androgen Receptor Pathway Inhibitor (ARPi)+Docetaxel: Patients initiating ARPi and docetaxel within 180 days start of ADT after Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) diagnosis