Clinical trial NCT02971085: Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance
Official title: Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: low-risk prostate cancer
active surveillance
pathologic reclassification
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 410
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean men with pathologically proven adenocarcinoma of prostate cancer with low-risk who will be treated by active surveillance protocol in Seoul National University Hospital.

Brief summary: In this study, the investigators aim to establish the prostate cancer active surveillance prospective cohort in our institution, and finally investigate the 5 year rates of reclassification during active surveillance as the primary endpoint of the current study.

Detailed description: Prostate cancer (PCa) remains one of the most commonly diagnosed malignancies in men worldwide. Early diagnosis and definitive therapy seem to improve oncological outcomes in men with high-risk disease, but significant concerns exist in terms of the overdiagnosis and overtreatment of patients with lower-risk tumors. In this context, active surveillance (AS) has recently emerged as a alternative treatment strategy in PCa patients with low risk cancers. However, published data are based on Western population with different protocol, and therefore; well-controlled data with well-organized and prospective cohort are urgently needed in Korean patients with low-risk PCa because Korean patients have significantly different tumor characteristics compared to Western patients. Here, the investigators have a plan to establish the Seoul National University Enrolled Registry for Prostate Cancer with Active Surveillance, and finally provide the concrete evidence for the clinical outcomes of active surveillance program as the primary therapeutic strategy for low-risk PCa in Korean men.

Eligibility criteria: Inclusion Criteria:

1. Men \< 80 years
2. Pathologically proven adenocarcinoma of the prostate by transrectal prostate biopsy ≥ 10 cores
3. Pre-Bx PSA ≤ 10ng/ml
4. PSA density \< 0.15ng/ml/ml
5. Clinical stage T1-2a
6. Biopsy Gleason score ≤ 6
7. No. of positive cores ≤ 2
8. Maximum cancer involvement in any one core ≤ 20%.
9. No PIRADS 5 lesion on multiparametric prostate MRI (1.5T or 3T)
10. Participants must be willing to attend the follow-up visits - T1a-b disease should be confirmed by systematic TRUS-Bx ≥ 10 cores

Exclusion Criteria:

1. A former therapy for prostate cancer.

Primary outcomes:
measure: Pathological reclassification
timeFrame: 5 year
Secondary outcomes:
measure: active treatment-free survival
timeFrame: 1, 3, 5, 7, 10 years
measure: metastasis-free survival
timeFrame: 3, 5, 10 years
measure: overall survival
timeFrame: 3, 5, 10 years
measure: rates of active surveillance maintenance
timeFrame: 1, 3, 5, 7, 10 years
measure: HRQoL scores (measured by EPIC-CP)
timeFrame: 1, 3, 5, 7, 10 years
measure: Utility value (measured by EQ-5D-5L)
timeFrame: 1, 3, 5, 7, 10 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chang Wook Jeong, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: