Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT06284304
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2024-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL
Sponsor:
The Netherlands Cancer Institute
Organization:
Study Overview
Official Title:
A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
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 v5.0) 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 v5.0) 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:
False
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?:
False
Is an FDA AA801 Violation?: