Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-28 @ 5:03 PM
Study NCT ID:
NCT02181192
Status:
UNKNOWN
Last Update Posted:
2016-08-01
First Post:
2014-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
Study Overview
Official Title:
Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1
Status:
UNKNOWN
Status Verified Date:
2016-07
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:
PROST-I
Brief Summary:
PSA-recurrence prostate carcinoma is associated with two general problems.
1. Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local, locoregional oder systemic relapse is available.
2. There is no standard therapy proved by randomised clinical trials. Recommended radiotherapy starting with PSA-value \< 0.5 ng/ml according to german S3 guidelines is based on retrospective data.
These difficulties may lead to a therapy potentially not adapted to patients situation of disease.This study aims to randomised examine if an instant radiotherapy of prostate PSA-recurrence (PSA-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with additional imaging (PSA value \>= 1 ng/ml) including PET/CT and bone scintigraphy for reliable information about tumor location and expansion is beneficial regarding therapy efficiency, quality of life and social economic aspects.
1. Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local, locoregional oder systemic relapse is available.
2. There is no standard therapy proved by randomised clinical trials. Recommended radiotherapy starting with PSA-value \< 0.5 ng/ml according to german S3 guidelines is based on retrospective data.
These difficulties may lead to a therapy potentially not adapted to patients situation of disease.This study aims to randomised examine if an instant radiotherapy of prostate PSA-recurrence (PSA-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with additional imaging (PSA value \>= 1 ng/ml) including PET/CT and bone scintigraphy for reliable information about tumor location and expansion is beneficial regarding therapy efficiency, quality of life and social economic aspects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: