Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585007
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-22
Brief Title:
Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer a Randomized Phase 3 Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDCARE
Brief Summary:
Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions
Detailed Description:
MEDCARE phase 3 trial is approved by the central Ethics committee It is a multicentric randomized prospective open-label two-arm phase III trial The aim is to evaluate the impact of progression-directed therapy PDT in patients presenting with oligoprogressive mCRPC on overall survival OS The study will employ a 11 randomization between arm A and arm B Patients will be stratified according to number of metastases 1 versus 1 initial localization local recurrence N or M1a vs M1b or M1c and systemic therapy patient type 1 vs type 2 see below Fig 1 Randomization will be carried out after approval in the multidisciplinary tumour board were the standard-of-care treatment and kind of PDT metastasectomy or SBRT will be decided before randomization
Study Oversight
Has Oversight DMC:
None
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?:
None