Ignite Creation Date:
2024-05-06 @ 2:19 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04283032
Status:
UNKNOWN
Last Update Posted:
2020-02-25
First Post:
2020-02-21
Brief Title:
Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer Cost-effectiveness Analysis
Sponsor:
InvestigatorUrologyIBSAL
Organization:
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Study Overview
Official Title:
Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer With Different Approaches Cost-effectiveness Analysis RMP-BX 2018-01
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RMPBX201801
Brief Summary:
Objectives To establish if there are differences between an ultrasound-guided transrectal prostate biopsy BPTE and a transperineal prostatic biopsy BPTP with and without a multiparametric Magnetic Resonance RMmp in patients with clinical suspicion of prostate cancer PC to first prostatic biopsy in terms of
1 Rate of detection and diagnosis of prostate cancer
2 Aggressiveness of the detected tumors
3 Association of the marker -2 proPSA and the prostate cancer health index PHI and microRNAs for the diagnosis of tumors
4 Adverse effects of the intervention and subjective perception of the patient pain and degree of satisfaction and impairment of quality of life
5 Cost-effectiveness analysis of the different intervention options
Study Design Randomized single-blind prospective clinical study to compare four schemes RMmp BPTE vs BPTE 12 cylinders vs RMmp BPTP vs BPTP 12 cylinders
Study population Patients with clinical suspicion of prostate cancer with PSA between 3-20 ng mL and normal or abnormal rectal examination candidates for a first prostate biopsy
Research techniques BPTE standard of 12 cylinders compared to RMmp previous to BPTE vs BPTP of 12 cylinders compared to BPTP with previous RMmp
1 Rate of detection and diagnosis of prostate cancer
2 Aggressiveness of the detected tumors
3 Association of the marker -2 proPSA and the prostate cancer health index PHI and microRNAs for the diagnosis of tumors
4 Adverse effects of the intervention and subjective perception of the patient pain and degree of satisfaction and impairment of quality of life
5 Cost-effectiveness analysis of the different intervention options
Study Design Randomized single-blind prospective clinical study to compare four schemes RMmp BPTE vs BPTE 12 cylinders vs RMmp BPTP vs BPTP 12 cylinders
Study population Patients with clinical suspicion of prostate cancer with PSA between 3-20 ng mL and normal or abnormal rectal examination candidates for a first prostate biopsy
Research techniques BPTE standard of 12 cylinders compared to RMmp previous to BPTE vs BPTP of 12 cylinders compared to BPTP with previous RMmp
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None