Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638541
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions - a Randomised Trial
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:
DESTINATION 2
Brief Summary:
DESTINATION 2 is a multi-centre randomised trial treating intermediate risk localised prostate cancer with 2 fraction Stereotactic Body Radiotherapy SBRT All radiotherapy will be delivered in two fractions sessions on an MR Linac using daily adaptation Men will either receive uniform dose radiotherapy or de-escalated dose radiotherapy The primary endpoint is acute GU CTCAE v5 grade 2 toxicity It will also look at late toxicity patient-reported outcome measures and PSA control
Detailed Description:
54 patients meeting inclusion criteria will be randomised between two arms Arm 1 Uniform dose will receive 27 Gy in 2 fractions to the whole prostate seminal vesicles SV the CTV with 0 mm CTV-PTV margin Arm 2 De-escalated dose will use two dose levels The benign prostate on MRI will receive 20 Gy in 2 fractions with a 0mm PTV margin The intraprostatic tumour masses as seen on MRI will receive 27 Gy in 2 fractions A 4mm GTV-PTV margin will be added to the MR visible tumour to form PTV 27Gy The primary endpoint is emergent acute GU CTCAE v5 Grade 2 toxicity recorded within 3 months of completing radiotherapy Secondary endpoints are CT CAE v5 acute GI toxicity late toxicity patient-reported outcome measures PROMs EPIC-26 IPSS and IIEF-5 at 4 and 12 weeks 6 months 1 and 2 years post treatment PSA control and kinetics
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