Trial Outcomes & Findings for A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces (NCT NCT06151418)

Last Updated: 2025-06-04

Results Overview

DOT was defined as the time from the index date to the date of NHT discontinuation for any reason. Discontinuation of the current NHT was defined as a treatment gap of at least 90 days (the last day with days' supply before the gap as discontinuation date), the initiation of a new therapy, or death, whichever came first. Initiation of a new therapy was defined by switching to a different NHT, switching to or augmentation with different therapies. Participants who did not experience discontinuation were censored at the end of data availability. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months).

Recruitment status

COMPLETED

Target enrollment

2313 participants

Primary outcome timeframe

From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 months

Results posted on

2025-06-04

Participant Flow

Data of participants diagnosed with metastatic castration-sensitive prostate cancer (mCSPC), who initiated Novel Hormonal Therapy (NHT) \[abiraterone, apalutamide, or enzalutamide\] in first line (1L) setting, any date (index date) from 01-Jan-2020 to 31-Dec-2022 were retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months). Retrospective data was evaluated from 22-Nov-2023 to 23-Apr-2024 (approximately 5 months) per objectives of the study.

Participant milestones

Participant milestones
Measure	Participant: NHT Eligible participants who initiated NHT as therapy including 1L to treat mCSPC in real world setting from 01-January-2020 to 31-December-2022, their data were evaluated as per objectives of this study. No intervention was administered under this observational study.
Overall Study STARTED	2313
Overall Study COMPLETED	2313
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data is reported as retrieved from medical records in accordance to protocol.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participant: NHT n=2313 Participants Eligible participants who initiated NHT as therapy including 1L to treat mCSPC in real world setting from 01-January-2020 to 31-December-2022, their data were evaluated as per objectives of this study. No intervention was administered under this observational study.
Age, Customized Age · 18-59 Years	99 Participants n=5 Participants
Age, Customized Age · 60-69 Years	451 Participants n=5 Participants
Age, Customized Age · 70-79 Years	1206 Participants n=5 Participants
Age, Customized Age · Greater than or equal to (>=) 80	557 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2313 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	1478 Participants n=5 Participants • Data is reported as retrieved from medical records in accordance to protocol.
Race/Ethnicity, Customized Black	522 Participants n=5 Participants • Data is reported as retrieved from medical records in accordance to protocol.
Race/Ethnicity, Customized Hispanic	114 Participants n=5 Participants • Data is reported as retrieved from medical records in accordance to protocol.
Race/Ethnicity, Customized Other	62 Participants n=5 Participants • Data is reported as retrieved from medical records in accordance to protocol.
Race/Ethnicity, Customized Unknown	137 Participants n=5 Participants • Data is reported as retrieved from medical records in accordance to protocol.

PRIMARY outcome

Timeframe: From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 months

Population: Analysis population included eligible participants whose data was retrieved and evaluated per objectives of this study.

Outcome measures

Outcome measures
Measure	Participant: NHT n=2313 Participants Eligible participants who initiated NHT as therapy including 1L to treat mCSPC in real world setting from 01-January-2020 to 31-December-2022, their data were evaluated as per objectives of this study. No intervention was administered under this observational study.
Duration of Therapy (DOT)	18.5 Months Interval 17.0 to 19.8

SECONDARY outcome

Timeframe: From start of index treatment until date of new therapy, or censoring date, whichever came first; during maximum follow-up of 45 months

Population: Analysis population included eligible participants whose data was retrieved and evaluated per objectives of this study.

TTNT was defined as the time from the index date to the initiation date of a new therapy. Initiation of a new therapy was defined by switching to a different NHT, switching to different therapies. Participants who did not initiate a new therapy were censored at the end of data availability or death, whichever came first. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months). Kaplan-Meier method was used for analysis.

Outcome measures

Outcome measures
Measure	Participant: NHT n=2313 Participants Eligible participants who initiated NHT as therapy including 1L to treat mCSPC in real world setting from 01-January-2020 to 31-December-2022, their data were evaluated as per objectives of this study. No intervention was administered under this observational study.
Time to Next Therapy (TTNT)	NA Months Median and 95% CI could not be estimated due to insufficient number of participants with event.

Adverse Events

Participant: NHT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER