Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04729114
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2021-01-15
Brief Title:
A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
Phase 1 Open-Label Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Prostate cancer is usually treated by reducing the amount of testosterone in the body PRL-02 depot is a potential treatment for men with advanced prostate cancer It is given by an injection into the muscle Men with advanced prostate cancer can take part in this study Their cancer has come back after previous cancer treatment or the previous cancer treatment they had didnt work
The main aims of the study are
to check the safety of PRL-02 depot given with and without another medicine called enzalutamide Enzalutamide blocks testosterone from reaching the prostate cancer cells
to check if the men can cope with tolerate PRL-02 depot given with or without enzalutamide
to find a suitable dose of PRL-02 depot
to check if blood levels of testosterone drop by a certain amount or go below a certain level
The level and amount were decided by the researchers before this study started
This study will be in 2 parts
In the first part different small groups of men will receive lower to higher doses of PRL-02 depot together with other medicines This will happen one group after another Earlier in the study the men received PRL-02 depot with a steroid called prednisone Now the men will either receive PRL-02 depot with a steroid called dexamethasone or PRL-02 depot with dexamethasone and enzalutamide Enzalutamide is known as an androgen receptor pathway inhibitor or ARPI
In the second part of the study men who have previously taken a hormone therapy medicine called abiraterone acetate or have previously taken 1 specific ARPI as part of their prostate cancer treatment can take part These ARPIs are enzalutamide apalutamide or darolutamide These men will receive the same dose of PRL-02 depot together with dexamethasone Men in both parts of the study will receive injections of PRL-02 depot into a muscle once every 12 weeks They will also take dexamethasone or prednisone or enzalutamide once a day The other medicines they take depends on which group and which part of the study they are in
The men will continue to receive PRL-02 depot with the other medicines until their blood level of testosterone rises above a certain level their cancer gets worse or they have medical problems they cant cope with They can also choose to stop taking part in the study at any time without giving a reason
During the study the men will visit the clinic several times for a health check This includes blood tests other standard safety checks and reporting any medical problems Scans will be done every 12 weeks
In both parts of the study after they finish their study treatment the men will visit the clinic for a final health check After this men whose cancer has not become worse will continue to be checked The clinic staff will phone the men after 4 weeks 30 days then every 12 weeks for an update on the mens health
The main aims of the study are
to check the safety of PRL-02 depot given with and without another medicine called enzalutamide Enzalutamide blocks testosterone from reaching the prostate cancer cells
to check if the men can cope with tolerate PRL-02 depot given with or without enzalutamide
to find a suitable dose of PRL-02 depot
to check if blood levels of testosterone drop by a certain amount or go below a certain level
The level and amount were decided by the researchers before this study started
This study will be in 2 parts
In the first part different small groups of men will receive lower to higher doses of PRL-02 depot together with other medicines This will happen one group after another Earlier in the study the men received PRL-02 depot with a steroid called prednisone Now the men will either receive PRL-02 depot with a steroid called dexamethasone or PRL-02 depot with dexamethasone and enzalutamide Enzalutamide is known as an androgen receptor pathway inhibitor or ARPI
In the second part of the study men who have previously taken a hormone therapy medicine called abiraterone acetate or have previously taken 1 specific ARPI as part of their prostate cancer treatment can take part These ARPIs are enzalutamide apalutamide or darolutamide These men will receive the same dose of PRL-02 depot together with dexamethasone Men in both parts of the study will receive injections of PRL-02 depot into a muscle once every 12 weeks They will also take dexamethasone or prednisone or enzalutamide once a day The other medicines they take depends on which group and which part of the study they are in
The men will continue to receive PRL-02 depot with the other medicines until their blood level of testosterone rises above a certain level their cancer gets worse or they have medical problems they cant cope with They can also choose to stop taking part in the study at any time without giving a reason
During the study the men will visit the clinic several times for a health check This includes blood tests other standard safety checks and reporting any medical problems Scans will be done every 12 weeks
In both parts of the study after they finish their study treatment the men will visit the clinic for a final health check After this men whose cancer has not become worse will continue to be checked The clinic staff will phone the men after 4 weeks 30 days then every 12 weeks for an update on the mens health
Detailed Description:
Phase 12a open-label multicenter study of intramuscular im PRL-02 depot in participants with castration-sensitive prostate cancer CSPC and metastatic castration-resistant prostate cancer mCRPC In Phase 1 Dose Escalation participants will receive escalating doses of im PRL-02 in 84-day treatment cycles combined with daily oral steroid
In Phase 2a Dose Expansion participants with metastatic castration-sensitive prostate cancer mCSPC and mCRPC will receive im PRL-02 at one or more recommended Phase 2 doses RP2Ds selected from Phase 1 in 84-day treatment cycles in combination with dexamethasone and docetaxel Group F1 or in combination with dexamethasone Groups F2 G In both phases participants will undergo scheduled periodic assessments of prostate specific antigen PSA testosterone and progesterone levels in the blood
In Phase 2a Dose Expansion participants with metastatic castration-sensitive prostate cancer mCSPC and mCRPC will receive im PRL-02 at one or more recommended Phase 2 doses RP2Ds selected from Phase 1 in 84-day treatment cycles in combination with dexamethasone and docetaxel Group F1 or in combination with dexamethasone Groups F2 G In both phases participants will undergo scheduled periodic assessments of prostate specific antigen PSA testosterone and progesterone levels in the blood
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