Clinical trial NCT05202301: A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely
Official title: Medication Adherence and Discontinuation Among Patients With Prostate Cancer Who Initiated Second Generation Androgen Receptor Inhibitors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-01-21
Enrollment: 13779
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with Prostate Cancer who newly initiate Second Generation Androgen Receptor Inhibitors treatment in United States from 01 Aug 2019 to 31 Mar 2021.

Brief summary: This is an observational study in which patient data from the past on men with prostate cancer are studied.

Cancer is a condition in which the body cannot control the growth of cells and tumors may form. If tumors form in the prostate, male sex hormones (androgens) can sometimes help the cancer spread and grow. Cancer that spreads to other parts of the body is called metastasis.

Androgens are mainly made in the testicles. There are treatments available for men with prostate cancer to lower the levels of these hormones in the body. These treatments are called androgen deprivation therapy (ADT). Some men with prostate cancer respond to ADT, but in some cases, prostate cancer may overcome the therapy and worsen despite low androgens levels.

Second generation androgen receptor inhibitors (SGARIs) including darolutamide, apalutamide, and enzalutamide are available for the treatment of prostate cancer in addition to ADT. SGARIs work by blocking androgens from attaching to proteins in cancer cells in the prostate.

Clinical studies have shown that men with prostate cancer benefit from these treatments. But besides benefits, unfavorable reactions related to these treatments also influence which treatment is chosen, if the treatment is taken as intended or if it is even stopped.

Unfavorable reactions observed for darolutamide, apalutamide, and enzalutamide differ from each other. In clinical trials, severe unfavorable reactions occurred less often for darolutamide.

But information on how unfavorable reactions of each treatment influence their intake in actual or "real-world" prostate cancer treatment is missing.

The main aim of this observational study is to learn to what extent SGARI treatments are taken as prescribed and how often their intake is completely stopped. To find this out, researchers will collect available treatment data of adult men with prostate cancer from the United States who started SGARI treatments between August 2019 and March 2021. The data will be drawn from the IQVIA database.

For each man, data from up to 1 year prior SGARI treatment until at least 3 months after treatment start (up to the 30 June 2021) will be collected.

The researchers will look at the percentage of men who:

* completely stopped to take their treatment or
* took the treatment as prescribed.

The results for each treatment (darolutamide, apalutamide, and enzalutamide) will then be compared to find possible differences.

There will be no required visits with a study doctor or required tests in this study since only patient data from the past are studied.


Eligibility criteria: Inclusion Criteria:

* Have at least 1 prescription claims for enzalutamide (National Drug Code \[NDC\]: 00469-0125-99, 00469-0625-99, 00469-0725-60), apalutamide (NDC: 59676-600-12, 59676-600-56, 59676-600-99) or darolutamide (NDC: 50419-395-01, 50419-395-72) during the index identification period.

  -- The date of the earliest SGARI claim to occur during this period will be defined as the index date with the corresponding SGARI as the index treatment.
* Have ≥1 diagnosis of prostate cancer (ICD-10 code C61.) during the overall baseline period.
* Age ≥18 years and male gender on the index date.
* Have continuous health plan enrollment with medical and pharmacy benefits for at least 6 months prior to the index date.
* Have continuous health plan enrollment with medical and pharmacy benefits for at least 3 months after the index date and throughout the follow-up period.

Exclusion Criteria:

* Since patients should not be prescribed more than one SGARI when initiating treatment, patients with more than one SGARI prescribed on the index date will be excluded from the study. This will allow each patient to be assigned to a single study cohort.
* In order to select patients who are initiating SGARI treatment, patients with the index SGARI treatment during the 1 year baseline period will be excluded from the study.

Primary outcomes:
measure: Discontinuation rate of SGARI treatment
timeFrame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
measure: Time to discontinuation (days) of SGARI treatment
timeFrame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
measure: Adherence of SGARI treatment
timeFrame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
Secondary outcomes:
measure: Treatment duration of SGARI treatment
timeFrame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
measure: Risk factors for treatment discontinuation
timeFrame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
measure: The proportion of patients who had evidence of dose modification of their index SGARI treatment
timeFrame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
measure: Time to first dose modification (days) of index SGARI treatment
timeFrame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021
measure: Descriptive summary of the baseline demographics of Prostate Cancer (PC) patients treated with SGARIs
timeFrame: Retrospective analysis during index identification period, from 01-Aug-2018 up to 31-Mar-2021
measure: Descriptive summary of the Comorbid conditions
timeFrame: Retrospective analysis from 01-Aug-2018 up to 31-Mar-2021
measure: Descriptive summary of the Charlson Comorbidity Index (CCI)
timeFrame: Retrospective analysis from 01-Aug-2018 up to 31-Mar-2021
measure: The proportion of patients who received different PC related medications
timeFrame: Retrospective analysis from 01-Aug-2018 up to 30-Jun-2021
measure: Descriptive summary of the baseline SGARI-class exposure status
timeFrame: Retrospective analysis from 01-Aug-2018 up to 31-Mar-2021
measure: Descriptive summary of the baseline Hormone sensitivity status
timeFrame: Retrospective analysis from 01-Aug-2018 up to 31-Mar-2021
Other outcomes:
Locations:
city: Whippany
country: United States
facility: Bayer
state: New Jersey
Study officials:
References: