Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320067
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-01-10
Brief Title:
A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
Studying Treatments in Patients Receiving Androgen Deprivation Therapy ADT and Androgen Receptor Signalling Inhibitors ARSI for Metastatic Prostate Cancer Evaluation of Drug and Radiation Efficacy A 2nd Multi-arm Multi-stage Randomised Controlled Trial STAMPEDE2
Status:
RECRUITING
Status Verified Date:
2024-08
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:
STAMPEDE2
Brief Summary:
STAMPEDE2 is a clinical trial comparing three new treatments with standard of care in people with prostate cancer that has spread to other parts of the body and is responsive to hormone therapy People from all backgrounds and ethnicities are encouraged to take part and multiple hospitals across the UK are involved University College London is running the trial
Each comparison within the trial has its own control arm where people get the best standard of care Arm A versus a research arm where a new treatment is added to standard of care
Participants are allocated to an arm by a computerised system with a 50 chance of getting the research treatment
Comparison S Arm A versus Arm S Stereotactic Ablative Body Radiotherapy SABR - Tests whether giving targeted doses of radiotherapy SABR to parts of the body where the cancer has spread slows the spread of the cancer and improves survival 2476 people will be in this comparison
Comparison P Arm A versus Arm P PSMA-Lutetium 177Lu-PSMA-617 - Tests whether giving a radioactive material 177Lu-PSMA-617 that targets prostate cancer cells slows the spread of the cancer and improves survival 1756 people will be in this comparison
Comparison N Arm AN versus Arm N Niraparib-Abiraterone AcetatePrednisolone Nira-AAP - Tests whether giving a new drug Nira-AAP slows the spread of the cancer and improves survival Only people with certain genetic changes in their tumour sample can take part in Comparison N 682 people will be in this comparison
Participants may be able to take part in more than one comparison
All participants will be followed up with scans and tests to monitor their cancer Doctors will check for any side effects from the treatments Treatments will be stopped if side effects are serious or people no longer wish to take the treatments
Each comparison within the trial has its own control arm where people get the best standard of care Arm A versus a research arm where a new treatment is added to standard of care
Participants are allocated to an arm by a computerised system with a 50 chance of getting the research treatment
Comparison S Arm A versus Arm S Stereotactic Ablative Body Radiotherapy SABR - Tests whether giving targeted doses of radiotherapy SABR to parts of the body where the cancer has spread slows the spread of the cancer and improves survival 2476 people will be in this comparison
Comparison P Arm A versus Arm P PSMA-Lutetium 177Lu-PSMA-617 - Tests whether giving a radioactive material 177Lu-PSMA-617 that targets prostate cancer cells slows the spread of the cancer and improves survival 1756 people will be in this comparison
Comparison N Arm AN versus Arm N Niraparib-Abiraterone AcetatePrednisolone Nira-AAP - Tests whether giving a new drug Nira-AAP slows the spread of the cancer and improves survival Only people with certain genetic changes in their tumour sample can take part in Comparison N 682 people will be in this comparison
Participants may be able to take part in more than one comparison
All participants will be followed up with scans and tests to monitor their cancer Doctors will check for any side effects from the treatments Treatments will be stopped if side effects are serious or people no longer wish to take the treatments
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1006437 | OTHER | IRAS | None |