Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439225
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-27
Brief Title:
Platinum and Taxane Chemo in Met Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes
Sponsor:
Canadian Cancer Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Phase III Trial Investigating Platinum and Taxane Chemotherapy in Metastatic Castration Resistant Prostate Cancer Patients With Alterations in DNA Damage Response Genes
Status:
NOT_YET_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:
OPTION-DDR
Brief Summary:
The usual approach for most patients who are not in a study is treatment with docetaxel
This study is being done to answer the following question Can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual approach
This study is being done to find out if this approach is better or worse than the usual approach for prostate cancer The usual approach is defined as the care most people get for prostate cancer
This study is being done to answer the following question Can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual approach
This study is being done to find out if this approach is better or worse than the usual approach for prostate cancer The usual approach is defined as the care most people get for prostate cancer
Detailed Description:
If taking part in this study the patient will either get docetaxel or carboplatin in addition to docetaxel In both cases the cancer will be monitored by CT scans and bone scans every 9 weeks and blood tests every 3 weeks Study treatments scans and tests will continue until the disease gets worse
After finishing study treatment even if treatment is stopped before the disease gets worse the study doctor will continue to follow patients condition watch for side effects and keep track of the health of the patient If treatment is stopped before the disease got worse patients will be asked to continue getting CT scans and bone scans every 9 weeks and blood tests every 3 weeks until the disease worsens If the disease gets worse while receiving treatment or after treatment is stopped the patient will be contacted by phone every 3 months for the rest of their life to monitor their status Patients may be seen more often if the study doctor thinks it is necessary
After finishing study treatment even if treatment is stopped before the disease gets worse the study doctor will continue to follow patients condition watch for side effects and keep track of the health of the patient If treatment is stopped before the disease got worse patients will be asked to continue getting CT scans and bone scans every 9 weeks and blood tests every 3 weeks until the disease worsens If the disease gets worse while receiving treatment or after treatment is stopped the patient will be contacted by phone every 3 months for the rest of their life to monitor their status Patients may be seen more often if the study doctor thinks it is necessary
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