Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223171
Status:
UNKNOWN
Last Update Posted:
2022-05-26
First Post:
2005-09-13
Brief Title:
Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Randomized Multicentre Phase III Study Assessment of the Duration of Androgen Blockade Combined With Pelvic Irradiation in High-risk Prostate Cancers
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
PCS IV
Brief Summary:
The objective of this study is to use as a reference the 36-month duration of hormonal therapy according to the European Organization for Research of the Treatment of Cancer EORTC protocol 22863 namely one-month of total androgen blockade followed by a luteinizing hormone releasing hormone LHRH agonist all for three years combined with pelvic and prostate irradiation this arm is currently considered to be a standard for high-risk prostate cancers The proposed study intends to challenge the duration of hormonal therapy and verify whether the five-year outcomes in favour of combined treatment in regard to survival 79 versus 62 and local control 85 versus 48 can be transposed for hormonal therapy that is half as long namely 18 months with the possibility of hormone salvage therapy in the event of biochemical andor clinical failure local regional or distant this applies to both arms The proposed study will compare survival in the two groups and evaluate in each one the total duration of initial hormonal therapy followed by initial hormonal therapy combined with salvage hormonal therapy the duration of salvage hormonal therapy until hormonal therapy resistance and the side effects of this hormonal therapy with everything being related to an assessment of the quality of life of these patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| DC-990-0056 | None | None | None |