Ignite Creation Date:
2024-05-06 @ 9:40 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03042312
Status:
TERMINATED
Last Update Posted:
2021-03-24
First Post:
2017-01-18
Brief Title:
Lutetium-177 Lu177 Prostate-Specific Antigen PSMA-Directed EndoRadiotherapy
Sponsor:
Endocyte
Organization:
Endocyte
Study Overview
Official Title:
PSMA-directed endoRadiothErapy of Castration-reSISTant Prostate Cancer RESIST-PC A Phase II Clinical Trial
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment was stopped before the target sample size was achieved
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESIST-PC
Brief Summary:
This was an open-label multicenter prospective trial to assess safety and efficacy of 177Lu-PSMA-617 in patients with metastatic castration resistant prostate cancer
Detailed Description:
Upon inclusion patients were randomized in a 11 ratio into two treatment doses Radioligand therapy RLT were performed by repeated intravenous iv injection of 60 gigabecquerel GBq - 10 or 74 GBq - 10 177Lu-PSMA-617 every 8- 1 weeks until reaching four cycles or threshold maximum dose to the kidneys of 23 Gray Gy All doses after labeling were presented in buffered solution for iv injection
In the initial plan for the study design a total of 200 patients with histologically proven prostate cancer and metastatic castration-resistant prostate cancer mCRPC were to be enrolled however due to early stopping of enrollment only 71 patients were enrolled at time of data base lock Each patient underwent a screening visit within 14 days prior to receiving study drug Treatment was continued until either of the following conditions applied
Prostate-specific antigen PSAradiographic progression at 12 weeks
Completion of four RLT cycles
23 Gy kidney dose would be exceeded by the next cycle as estimated by dosimetry
Patient withdrawal eg appearance of intolerable adverse events
In the initial plan for the study design a total of 200 patients with histologically proven prostate cancer and metastatic castration-resistant prostate cancer mCRPC were to be enrolled however due to early stopping of enrollment only 71 patients were enrolled at time of data base lock Each patient underwent a screening visit within 14 days prior to receiving study drug Treatment was continued until either of the following conditions applied
Prostate-specific antigen PSAradiographic progression at 12 weeks
Completion of four RLT cycles
23 Gy kidney dose would be exceeded by the next cycle as estimated by dosimetry
Patient withdrawal eg appearance of intolerable adverse events
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 |
|---|---|---|---|
| 133661 | OTHER | Original sponsor | None |