Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523634
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-28
Brief Title:
Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Salvage Stereotactic Body Radiotherapy of the Prostate Bed for Biochemical Recurrence After Radical Prostatectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
STEREOBED
Brief Summary:
This is a a randomized phase IIIII trial comparing salvage SBRT with standard of care SOC regimens for patients with a persistent detectable PSA or biochemical progression during follow-up after radical prostatectomy
Detailed Description:
This is a multicentric randomized seamless phase IIIII study comparing SBRT to conventional RT or moderately hypofractionated RT on the prostate bed
All subjects will be randomly assigned in a 11 ratio
1 Experimental arm Radiotherapy treatment of prostate bed in 5 fractions
2 Control arm Radiotherapy treatment of prostate bed within a normofractionated or mildly hypofractionated schedule For the control arm each participating center can choose between a normofractionated schedule 32 to 35 treatment sessions and a moderately hypofractionated schedule 20 sessions
All subjects will be randomly assigned in a 11 ratio
1 Experimental arm Radiotherapy treatment of prostate bed in 5 fractions
2 Control arm Radiotherapy treatment of prostate bed within a normofractionated or mildly hypofractionated schedule For the control arm each participating center can choose between a normofractionated schedule 32 to 35 treatment sessions and a moderately hypofractionated schedule 20 sessions
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