Real World Outcome Analysis for APAC High Risk Localized Prostate Cancer Patients Treated With Radical Prostatectomy and Perioperative Hormonal Therapy

Real World Outcome Analysis for APAC High Risk Localized Prostate Cancer Patients Treated With Radical Prostatectomy and Perioperative Hormonal Therapy - ACE Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047622

Enrollment

600

Registered

2022-05-01

Start date

2022-06-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Risk Localized Prostate Cancer

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1.>=18 years of age at time of LPC diagnosis 2.Histologically confirmed adenocarcinoma of the prostate 3.Newly diagnosed between 1 January 2015 to 30 June 2017 (both dates inclusive) 4.High risk localized prostate cancer, as defined by NCCN prostate cancer guideline (2020 version 1) 5.Must have received radical prostatectomy between 1 January 2015 and 30 June 2017 6.Must have received at least 1 perioperative hormonal therapy pattern: a.>=3 months neoadjuvant hormonal therapy, duration between date of last dose and date of RP should be <=2 months; AND / OR b.>=6 months adjuvant hormonal therapy, first dose started within 6 months of RP surgery

Exclusion criteria

Exclusion criteria: Distant metastasis based on conventional imaging (clinical stage M1) at time of prostate cancer diagnosis

Design outcomes

Primary

Measure	Time frame
Among HR LPC patients following RP and perioperative hormonal therapies: Evaluate the yearly conditional prostate-specific antigen (PSA) progression-free survival probabilities over 5 years	—

Secondary

Measure	Time frame
Among HR LPC patients following RP and perioperative hormonal therapies: Secondary objective #1: Describe patient characteristics (including stage at diagnosis and time from diagnosis to RP) Secondary objective #2: Describe treatments provided with RP and following RP including: a.Treatments received (RP and neo-adjuvant hormonal therapy only, RP and adjuvant hormonal therapy only, or RP and both neo-adjuvant and adjuvant hormonal therapies) b.Hormonal therapy duration Secondary objective #3: Evaluate the yearly local or distant radiographic progression-free survival probabilities over 5 years Exploratory objective #1 (if data permits): Evaluate median time to PSA progression Exploratory objective #2 (if data permits): Describe rate of pathologic complete response (pCR) in HR LPC patients who received RP and: a.neoadjuvant hormonal therapy only b.adjuvant hormonal therapy only c.both neoadjuvant and adjuvant hormonal therapies Exploratory objective #3 (if data permits): Describe rate of negative margin in HR LPC patients who received RP and: a.neoadjuvant hormonal therapy only b.adjuvant hormonal therapy only c.both neoadjuvant and adjuvant hormonal therapies Exploratory objective #4 (if data permits): Describe rate of HR LPC patients receiving RP and hormonal therapies among: a.newly diagnosed HR LPC patients b.newly diagnosed HR LPC patients who received RP	—

Measure

Time frame

Among HR LPC patients following RP and perioperative hormonal therapies: Secondary objective #1: Describe patient characteristics (including stage at diagnosis and time from diagnosis to RP) Secondary objective #2: Describe treatments provided with RP and following RP including: a.Treatments received (RP and neo-adjuvant hormonal therapy only, RP and adjuvant hormonal therapy only, or RP and both neo-adjuvant and adjuvant hormonal therapies) b.Hormonal therapy duration Secondary objective #3: Evaluate the yearly local or distant radiographic progression-free survival probabilities over 5 years Exploratory objective #1 (if data permits): Evaluate median time to PSA progression Exploratory objective #2 (if data permits): Describe rate of pathologic complete response (pCR) in HR LPC patients who received RP and: a.neoadjuvant hormonal therapy only b.adjuvant hormonal therapy only c.both neoadjuvant and adjuvant hormonal therapies Exploratory objective #3 (if data permits): Describe rate of negative margin in HR LPC patients who received RP and: a.neoadjuvant hormonal therapy only b.adjuvant hormonal therapy only c.both neoadjuvant and adjuvant hormonal therapies Exploratory objective #4 (if data permits): Describe rate of HR LPC patients receiving RP and hormonal therapies among: a.newly diagnosed HR LPC patients b.newly diagnosed HR LPC patients who received RP

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Countries

Japan,Asia(except Japan)

Contacts

Public ContactMaki Hosokawa

IQVIA Services Japan K.K. Real World Evidence Services

Maki.Hosokawa@iqvia.com08040924367

Outcome results