Longitudinal intervention study using interim treatment-free observation as the initial treatment strategy for stage T1c prostate cancer

Longitudinal intervention study using interim treatment-free observation as the initial treatment strategy for stage T1c prostate cancer - Longitudinal intervention study for non-palpable prostate cancer using temporary observation without treatment as initial treatment strategy

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052842

Enrollment

100

Registered

2023-11-19

Start date

2002-01-01

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

prostate cancer

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: PSA 20 ng/ml or less, Gleason score 3+3 or less, 2 positive cores or less , and maximum cancer occupancy (within positive cores) less than 50%

Exclusion criteria

Exclusion criteria: Patients with a history of cerebral infarction, unstable angina, diabetes uncontrolled by insulin, severe hypertension, or myocardial infarction within 6 months

Design outcomes

Primary

Measure	Time frame
Proportion of patients with a PSA doubling time of more than 2 years at 6 months after enrollment among patients selected for active surveillance	—

Secondary

Measure	Time frame
1) Percentage of patients who met the pathological eligibility criteria at the time of enrollment as a result of re-biopsy among patients selected for active surveillance who underwent re-biopsy performed 13 months after enrollment 2) Percentage of patients who underwent total prostatectomy as the first treatment for prostate cancer within 6 months of enrollment who had a pathology diagnosis of Non Organ Confined Disease in the resected specimen. 3) Adverse events in patients receiving active treatment 4) Degree of decline in her QOL in patients choosing active surveillance and patients choosing active treatment 5) Overall survival time in patients who selected active surveillance and patients who selected active therapy 6) Metastasis-free survival time in patients who selected active surveillance and patients who selected active therapy	—

Measure

Time frame

1) Percentage of patients who met the pathological eligibility criteria at the time of enrollment as a result of re-biopsy among patients selected for active surveillance who underwent re-biopsy performed 13 months after enrollment 2) Percentage of patients who underwent total prostatectomy as the first treatment for prostate cancer within 6 months of enrollment who had a pathology diagnosis of Non Organ Confined Disease in the resected specimen. 3) Adverse events in patients receiving active treatment 4) Degree of decline in her QOL in patients choosing active surveillance and patients choosing active treatment 5) Overall survival time in patients who selected active surveillance and patients who selected active therapy 6) Metastasis-free survival time in patients who selected active surveillance and patients who selected active therapy

—

Countries

Japan

Contacts

Public ContactTakuma Kato

Kagawa university Department of Urology, Faculty of Medicine

kato.takuma@kagawa-u.ac.jp0878912202

Outcome results