Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06080113
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-18
First Post:
2023-04-24
Brief Title:
Cancer of the Prostate Treated With Focal Implantation of a RadioactivE Source
Sponsor:
Herlev Hospital
Organization:
Herlev Hospital
Study Overview
Official Title:
Cancer of the Prostate Treated With Focal Implantation of a RadioactivE Source - The Introduction of Prostate Cancer Targeted Focal Therapy Treatment in Denmark
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-01
Last Known Status:
None
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:
CAPFIRE
Brief Summary:
The purpose is to assess and describe the oncological and functional outcomes following the introduction of curative targeted focal brachytherapy of prostate cancer in Denmark
Men with a single MRI-identifiable prostate cancer index-tumour who fulfil inclusion criteria and are candidates for curative treatment Eligible men will undergo curative intended targeted focal brachytherapy for treatment of histologically confirmed prostate cancer
The intervention will include Low- LDR or High HDR dose rate targeted focal brachytherapy of prostate cancer Collection of data on safety morbidity side effects and quality of life Collection of clinical data on treatment efficacy progression and mortality
All patients will have a follow up of 10-years for oncological outcome 5-years for acute- and late toxicity- and 2-years for functional outcomes respectively The follow up will include clinical data MRI confirmatory biopsies and questionnaires at specific fixed time points pre-and post-operatively after 1-3 days 4-weeks 3- 6-- 9- 12- 18- and 24-months followed by every 6 months up to 5-yr and then every year up to 10-yr follow-up
Anticipated number of patients is 50 and regular analysis and reporting will be performed continuously The first short-term analysis will be after 18-months of follow-up after confirmatory MRI and biopsies and the final reporting will be after 10-years follow-up in 2035
Men with a single MRI-identifiable prostate cancer index-tumour who fulfil inclusion criteria and are candidates for curative treatment Eligible men will undergo curative intended targeted focal brachytherapy for treatment of histologically confirmed prostate cancer
The intervention will include Low- LDR or High HDR dose rate targeted focal brachytherapy of prostate cancer Collection of data on safety morbidity side effects and quality of life Collection of clinical data on treatment efficacy progression and mortality
All patients will have a follow up of 10-years for oncological outcome 5-years for acute- and late toxicity- and 2-years for functional outcomes respectively The follow up will include clinical data MRI confirmatory biopsies and questionnaires at specific fixed time points pre-and post-operatively after 1-3 days 4-weeks 3- 6-- 9- 12- 18- and 24-months followed by every 6 months up to 5-yr and then every year up to 10-yr follow-up
Anticipated number of patients is 50 and regular analysis and reporting will be performed continuously The first short-term analysis will be after 18-months of follow-up after confirmatory MRI and biopsies and the final reporting will be after 10-years follow-up in 2035
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