Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204341
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2024-01-03
Brief Title:
Towards Optimal Treatment for High Risk Prostate Cancer
Sponsor:
Haaglanden Medical Centre
Organization:
Haaglanden Medical Centre
Study Overview
Official Title:
Towards Optimal Treatment for High Risk Prostate Cancer Stereotactic Pelvic Radiotherapy with Focal Boost to the Primary Tumour
Status:
RECRUITING
Status Verified Date:
2024-01
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:
HYPOPRIME
Brief Summary:
The goal of this clinical trial is to combine several optimized treatments of high risk prostate cancer The main question to answer is is it safe to combine these optimized treatments
patients will be irradiated on the prostate and elective lymph nodes more concentrated but with fewer hospital visits hypofractionation
the tumor will get a higher dose
androgen deprivation therapy will be reduced as much al possible preventing side effects
Researchers will compare oncological outcome and toxicity
patients will be irradiated on the prostate and elective lymph nodes more concentrated but with fewer hospital visits hypofractionation
the tumor will get a higher dose
androgen deprivation therapy will be reduced as much al possible preventing side effects
Researchers will compare oncological outcome and toxicity
Detailed Description:
Rationale Recently several randomized trial have shown benefits of changes made to radiotherapy of high risk localized prostate cancer patients A focal boost was shown to improve outcome in men with intermediatehigh risk prostate cancer FLAME trial Elective lymph node irradiation was shown to improve outcome in high risk prostate cancer patients POP-RT Extreme hypo fractionation was shown to be safe for lowintermediate risk prostate cancer patients In addition the added benefit of ADT with substantial toxicity seems reduced with improvements made to treatment and diagnosis in recent years DART 0105 own recent work on this topic to be published None off the above were combined into one ideal treatment for high risk prostate cancer
Objective Determine the safety oncological outcome and toxicity of an comprehensive treatment combining recent advances in the treatment of high risk prostate cancer
Study design prospective cohort study with matched contemporary control group Study population Men with high risk prostate cancer with an indication for elective lymph node irradiation Intervention hypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate Main study parametersendpoints biochemical recurrence free survival and late toxicity Nature and extent of the burden and risks associated with participation benefit and group relatedness The additional burden of the study is considered to be low as additional tests or site visits in comparison to current clinical follow up are not planned Regarding safety different parts of the investigational treatment were already shown to be safe in previous studies The current study aims to combine these different parts into one treatment We estimate that the risks associated with combining these treatments are very limited
Objective Determine the safety oncological outcome and toxicity of an comprehensive treatment combining recent advances in the treatment of high risk prostate cancer
Study design prospective cohort study with matched contemporary control group Study population Men with high risk prostate cancer with an indication for elective lymph node irradiation Intervention hypo fractionated pelvic radiotherapy with boost to primary tumour in the prostate Main study parametersendpoints biochemical recurrence free survival and late toxicity Nature and extent of the burden and risks associated with participation benefit and group relatedness The additional burden of the study is considered to be low as additional tests or site visits in comparison to current clinical follow up are not planned Regarding safety different parts of the investigational treatment were already shown to be safe in previous studies The current study aims to combine these different parts into one treatment We estimate that the risks associated with combining these treatments are very limited
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