Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance

Prostate Cancer Clinical Trial

— SUPER-PC-AS  

Official title:

Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02971085
• Other study ID #: 2016-2957
• Status: Recruiting
• Start date: December 2016
• Est. completion date: January 2027

Study information

• Verified date: February 2019
• Source: Seoul National University Hospital
• Contact: Min Ji Seo, Bachelor
• Phone: +82-2-2072-3899
• Email: seomj0722[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 410
• Est. completion date: January 2027
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Active surveillance
Active surveillance cohorts are routinely performed the systematic biopsy = 12 cores by TRUS-guided or MR-TRUS fusion according to the protocol based by time path as 1, 2, 4, 7, 10 years and subsequently every 5 years following initial TRUS biopsy.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological reclassification	5-year rate of pathological reclassification during active surveillance	5 year
Secondary	active treatment-free survival	active treatment-free survival rate	1, 3, 5, 7, 10 years
Secondary	metastasis-free survival	metastasis-free survival rate	3, 5, 10 years
Secondary	overall survival	overall survival rate	3, 5, 10 years
Secondary	rates of active surveillance maintenance	rates of active surveillance maintenance	1, 3, 5, 7, 10 years
Secondary	HRQoL scores (measured by EPIC-CP)	HRQoL scores (measured by EPIC-CP)	1, 3, 5, 7, 10 years
Secondary	Utility value (measured by EQ-5D-5L)	Utility value (measured by EQ-5D-5L)	1, 3, 5, 7, 10 years