Viewing Study NCT06179706



Ignite Creation Date: 2024-05-06 @ 7:53 PM
Last Modification Date: 2024-10-26 @ 3:16 PM
Study NCT ID: NCT06179706
Status: COMPLETED
Last Update Posted: 2024-03-06
First Post: 2023-11-30

Brief Title: 11C-choline PETCT Based Helical Tomotherapy as Innovative Treratment Approach for Bone Metastases in Prostate Cancer Patients
Sponsor: IRCCS San Raffaele
Organization: IRCCS San Raffaele

Study Overview

Official Title: 11C-choline PETCT Based Helical Tomotherapy as Innovative Treratment Approach for Bone Metastases in Prostate Cancer Patients
Status: COMPLETED
Status Verified Date: 2024-03
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: None
Brief Summary: The number of metastases may reflect the biological aggressiveness of the tumor and may determine the possibility of performing potential curative interventions such as surgery or high-dose targeted radiotherapy RT Until a few years ago the treatment of choice for metastatic prostate cancer was androgen deprivation TDA This treatment was carried out as palliative care in order to postpone the progression of the disease or reduce symptoms Patients with prostate cancer with a limited number of metastases similarly to patients suffering from other solid tumors can be considered as patients with disease that has limited capacity to cause further secondary effects In this scenario the primary treatment in patients with carcinoma localized prostate is characterized by radical prostatectomy followed by measurement of prostate specific antigen PSA during follow-up After primary prostatectomy PSA values 02 ngmL are indicative of disease recurrence but it is not possible to determine whether the recurrence is local or distant Furthermore imaging modalities such as bone scanning and computed tomography CT do not have sufficient sensitivity to detect the presence of metastatic disease in patients with low PSA levels Positron emission tomographyCT with 11C-choline is able to detect local or distant metastases with a sensitivity and specificity greater than 85 in patients with biochemical disease recurrence 11C-Choline PETCT can be a valid tool both for diagnosis and for guiding radiotherapy treatments in these patients for whom it is not possible to obtain a definitive diagnosis with conventional diagnostic procedures There are currently few studies that have described the use of 11C-choline PETCT to guide treatment for bone metastases the limitations of these studies concern the small number of patients and the short follow-up The aim of this retrospective observational study was to evaluate the efficacy of 11C-choline PETCT as a guide to the treatment of helical tomotherapy for an innovative therapeutic approach in bone metastases in a population of patients affected by prostate cancer with a limited number of metastasis
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