Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06273345
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-06
Brief Title:
OLIGOS Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
Sponsor:
Istituto Oncologico Veneto IRCCS
Organization:
Istituto Oncologico Veneto IRCCS
Study Overview
Official Title:
OLIGOS Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate
Status:
RECRUITING
Status Verified Date:
2024-02
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:
OLIGOS
Brief Summary:
The proposed study consists of a multicentre prospective observational study involving patients with oligometastatic prostatic neoplasia defined according to CHAARTED criteria
The aim of the study is the creation of a registry including patients with newly diagnosed OMPCa belonging to the main urological centres in the Triveneto region in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm surgical or radiotherapy in addition to systemic hormonal treatment ADT as monotherapy or in combination with Docetaxelandrogen receptor signal inhibitors ARTA
The above criteria define high metastatic volume disease with the following parameters
4 bone metastases including at least one outside the spine and pelvis
Presence of visceral metastases Consequently patients included in the study should not have the above-mentioned characteristics
The aim of the study is the creation of a registry including patients with newly diagnosed OMPCa belonging to the main urological centres in the Triveneto region in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm surgical or radiotherapy in addition to systemic hormonal treatment ADT as monotherapy or in combination with Docetaxelandrogen receptor signal inhibitors ARTA
The above criteria define high metastatic volume disease with the following parameters
4 bone metastases including at least one outside the spine and pelvis
Presence of visceral metastases Consequently patients included in the study should not have the above-mentioned characteristics
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