Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257693
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2023-12-14
Brief Title:
Enzalutamide Implants Enolen in Patients With Prostate Cancer
Sponsor:
Alessa Therapeutics Inc
Organization:
Alessa Therapeutics Inc
Study Overview
Official Title:
A Phase 1 Study to Establish the Feasibility of Enolen tm for the Local Delivery of Enzalutamide in Patients With Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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 study is to assess whether the Enolen is safe and delivers anti-androgen medication locally in patients that are planning for radical prostatectomy
Detailed Description:
This study is a single-center open-label feasibility study Up to 20 participants planning for radical prostatectomy will be recruited to assess the safety and patient tolerance of Enolen for the localized delivery of enzalutamide into the prostate
At baseline patients will undergo multiparametric MRI of the prostate Study participants will have placement of the drug eluting Enolen implants Six to twelve weeks later the patient will undergo a repeat MRI followed by standard of care radical prostatectomy
Participants will be followed for an additional 6-12 weeks post surgery Clinical labs and correlative sample collection and patient quality of life questionnaires will be administered at follow-up visits
At baseline patients will undergo multiparametric MRI of the prostate Study participants will have placement of the drug eluting Enolen implants Six to twelve weeks later the patient will undergo a repeat MRI followed by standard of care radical prostatectomy
Participants will be followed for an additional 6-12 weeks post surgery Clinical labs and correlative sample collection and patient quality of life questionnaires will be administered at follow-up visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ZIABC011081 | NIH | None | httpsreporternihgovquickSearchZIABC011081 |