Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654336
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Study of Recurrence-directed Therapy RDT With or Without Androgen-Deprivation Therapy ADT In Patients With Radio-recurrent Oligo-metastatic HormoneCastrate Sensitive Prostate Cancer romCSPC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Randomized Trial of Recurrence-directed Therapy RDT With or Without Androgen-Deprivation Therapy ADT In Radio-recurrent Oligo-metastatic HormoneCastrate Sensitive Prostate Cancer romCSPC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RATIONAL-PCS
Brief Summary:
The goal of this study is to determine whether the addition of Androgen Deprivation Therapy ADT utilizing the study drug ELIGARD to Recurrence- Directed Therapy RDT improves progression-free survival PFS compared to RDT alone in patients with early radio-recurrent oligo-metastatic castrate hormone sensitive prostate cancer romCSPC Participants will be assessed at standard of care clinic visits every 3 months The follow-up period is 36 months
Detailed Description:
A multi-centre open-label phase II randomized clinical trial evaluating the addition of Androgen Deprivation Therapy ADT utilizing the study drug ELIGARD compared to Recurrence Directed Therapy RDT alone in patients with previously localized prostate adenocarcinoma treated with definitive radiotherapy or with salvage radiotherapy after radical prostatectomy who experience biochemical recurrence and present with oligo-metastases ie 5 sites of metastases on conventional imaging Eligible and consenting patents will be randomized in a 11 fashion to either RDT alone standard arm or RDT ADT ELIGARD x12 months experimental arm During treatment study participants will be assessed for disease progression development of castrate resistant prostate cancer CRPC acute and late genitourinary GU and gastrointestinal GI radiotherapy toxicity the occurrence of adverse events initiation of tertiary therapy overall survival and quality of life through the completion of participant questionnaires Participants will be assessed at standard of care clinic visits every 3 months The follow-up period is 36 months from the date of randomization The planned sample size is 162 study participants
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