Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284304
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-05
Brief Title:
A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL
Sponsor:
The Netherlands Cancer Institute
Organization:
The Netherlands Cancer Institute
Study Overview
Official Title:
A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
DESTINATION
Brief Summary:
Trial design A single centre phase II non-randomised study
Trial population Men with intermediate risk localised prostate cancer
Recruitment target 20 patients in total
Trial objectives
Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects
Secondary
To assess levels of acute GU and GI toxicity CTCAE
To assess levels of late GU and GI toxicity CTCAE
To assess late sexual quality of life expanded EPIC IIEF-5
To assess biochemical relapse-free survival at 2 years
Trial treatment All radiotherapy will be delivered on the MR-linac Intraprostatic dose will be varied according to risk of local recurrence based on mpMRI PSA and histology The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription
Trial population Men with intermediate risk localised prostate cancer
Recruitment target 20 patients in total
Trial objectives
Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects
Secondary
To assess levels of acute GU and GI toxicity CTCAE
To assess levels of late GU and GI toxicity CTCAE
To assess late sexual quality of life expanded EPIC IIEF-5
To assess biochemical relapse-free survival at 2 years
Trial treatment All radiotherapy will be delivered on the MR-linac Intraprostatic dose will be varied according to risk of local recurrence based on mpMRI PSA and histology The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription
Detailed Description:
Primary endpoint Technical feasibility of treating prostate cancer with toxicity- minimising radiotherapy on an MR-linac
Secondary endpoint
Physician reported GU and gastrointestinal GI toxicity CTCAE grade at baseline and the end of treatment then at 4 weeks and 3 months post-treatment
Late toxicity CTCAE v50 at 1 and 2 years post-treatment
Patient-reported outcome measures PROMs from the EPIC-26 IPSS and IIEF-5 questionnaires Patients will be asked to complete PROMs at 4 weeks 3 and 6 months 1 and 2 years post treatment
PSA control and kinetics at 2 years post-treatment
Quality of life EPIC-26 QoL will be measured at baseline then at 4 weeks and 3 6 12 and 24 months from end of treatment IIEF-5 will be completed at baseline and months 6 12 and 24 IPSS will be measured at all time points
Follow-up Patients will be assessed at 6 12 and 24 months and then as per standard of care
Secondary endpoint
Physician reported GU and gastrointestinal GI toxicity CTCAE grade at baseline and the end of treatment then at 4 weeks and 3 months post-treatment
Late toxicity CTCAE v50 at 1 and 2 years post-treatment
Patient-reported outcome measures PROMs from the EPIC-26 IPSS and IIEF-5 questionnaires Patients will be asked to complete PROMs at 4 weeks 3 and 6 months 1 and 2 years post treatment
PSA control and kinetics at 2 years post-treatment
Quality of life EPIC-26 QoL will be measured at baseline then at 4 weeks and 3 6 12 and 24 months from end of treatment IIEF-5 will be completed at baseline and months 6 12 and 24 IPSS will be measured at all time points
Follow-up Patients will be assessed at 6 12 and 24 months and then as per standard of care
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