Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518226
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk Localized Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk Localized Prostate Cancer TURBO Phase 2 Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
TURBO
Brief Summary:
The goal of this clinical trial is to assess the non-inferiority irradiating low and intermediate risk localized prostate cancer in two fractions of radiotherapy compared to five fractions of radiotherapy which is the standard of care The main question it aims to answer are
- Do participants in the interventional arm have more physician-reported grade 2 or higher acute Common Terminology Criteria for Adverse Events CTCAE genitourinary GU side effects
Participants in the intervention arm will receive two fractions of radiotherapy in which the prostate is irradiated with 12 Gy per fraction and the tumor receives a boost of up to 135 Gray Gy over the course of 8 days Those in the control arm will receive five fractions of radiotherapy of 725 Gy each to the prostate without a boost to the tumor over the course of 16-18 days
- Do participants in the interventional arm have more physician-reported grade 2 or higher acute Common Terminology Criteria for Adverse Events CTCAE genitourinary GU side effects
Participants in the intervention arm will receive two fractions of radiotherapy in which the prostate is irradiated with 12 Gy per fraction and the tumor receives a boost of up to 135 Gray Gy over the course of 8 days Those in the control arm will receive five fractions of radiotherapy of 725 Gy each to the prostate without a boost to the tumor over the course of 16-18 days
Detailed Description:
Rationale Hypofractionation in prostate cancer radiotherapy has already led to a drastic reduction in fractionation scheme from 35 fractions to the now standard 5 fractions for patients with intermediate risk prostate cancer Currently biochemical progression free survival is at approximately 90 at five-year follow-up for intermediate risk prostate cancer patients which leaves little to no room for further improvement in oncological outcomes However with an ageing population and a subsequently higher volume of patients with localized prostate cancer there is a need to improve and optimize current treatment options Treatment cost within the field of prostate oncology will further increase over the years to come and an early economic health evaluation has demonstrated that a 2-fractionation scheme with MRI-guided radiotherapy MRgRT for intermediate risk prostate cancer patients is cost effective compared to the standard of care 5 fractions scheme
Previous research demonstrated the feasibility of delivering high doses of radiation in only two fractions both in silico as well as in a clinical setting using a conventional CT-guided linear accelerator With the introduction of MRgRT however it has become possible to deliver higher doses of radiation with more accuracy while limiting genitourinary GU and gastrointestinal GI toxicity This leads us to believe that improvements can be made both in terms of costs as well as patient reported quality of life
Objective To assess the effectiveness safety and feasibility of treating patients with localized intermediate risk prostate cancer who will receive radiation therapy in two fractions of 12 Gy with a boost to the gross tumor volume of 135 Gy per fraction in 8 days as compared to standard care 3625 Gy in five fractions in 16-18 days on an ELEKTA Unity MR-Linac system
Study design Single-center prospective open label phase II randomized controlled trial
Study population Men with localized intermediate risk prostate cancer who are to receive radiation therapy with curative intent Exclusion criteria are previous radical prostatectomy presence of contraindications for MRI or conditions which predispose to increased morbidity andor toxicity such as colitis ulcerosa Crohns disease previous pelvic radiotherapy metal pelvic implants causing artefact of MR-imaging and previous invasive malignancy within the last 5 year excluding cutaneous basal cell carcinoma
Intervention Participants in the intervention arm will receive two fractions of 12 Gy to the clinical target volume CTV with a boost up to 135 Gy to the gross tumor volume GTV of radiation in a time span of 8 days on an MR-linac Those in the control arm will receive five fractions of 725 Gy in a time span of 16-18 days on an MR-linac as per standard care
Main study parametersendpoints Difference in proportion of participants with acute CTCAE grade 2 or higher GU toxicity
Nature and extent of the burden and risks associated with participation benefit and group relatedness This trial will be nested in the observational Multiple OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac MOMENTUM study and participants will receive QOL questionnaires which are already embedded within this cohort Therefore participants are not subjected to an additional burden during the course and follow-up period of this study In a recently published study there was no evidence that hypofractionation caused more GU andor GI grade 2 toxicity Radiobiologically the low alphabeta ratio of prostate cancer makes it more sensitive to higher doses of radiation in fewer fractions which is in fact the essence of the ultrahypofractionation scheme that we offer in the interventional arm
Previous research demonstrated the feasibility of delivering high doses of radiation in only two fractions both in silico as well as in a clinical setting using a conventional CT-guided linear accelerator With the introduction of MRgRT however it has become possible to deliver higher doses of radiation with more accuracy while limiting genitourinary GU and gastrointestinal GI toxicity This leads us to believe that improvements can be made both in terms of costs as well as patient reported quality of life
Objective To assess the effectiveness safety and feasibility of treating patients with localized intermediate risk prostate cancer who will receive radiation therapy in two fractions of 12 Gy with a boost to the gross tumor volume of 135 Gy per fraction in 8 days as compared to standard care 3625 Gy in five fractions in 16-18 days on an ELEKTA Unity MR-Linac system
Study design Single-center prospective open label phase II randomized controlled trial
Study population Men with localized intermediate risk prostate cancer who are to receive radiation therapy with curative intent Exclusion criteria are previous radical prostatectomy presence of contraindications for MRI or conditions which predispose to increased morbidity andor toxicity such as colitis ulcerosa Crohns disease previous pelvic radiotherapy metal pelvic implants causing artefact of MR-imaging and previous invasive malignancy within the last 5 year excluding cutaneous basal cell carcinoma
Intervention Participants in the intervention arm will receive two fractions of 12 Gy to the clinical target volume CTV with a boost up to 135 Gy to the gross tumor volume GTV of radiation in a time span of 8 days on an MR-linac Those in the control arm will receive five fractions of 725 Gy in a time span of 16-18 days on an MR-linac as per standard care
Main study parametersendpoints Difference in proportion of participants with acute CTCAE grade 2 or higher GU toxicity
Nature and extent of the burden and risks associated with participation benefit and group relatedness This trial will be nested in the observational Multiple OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac MOMENTUM study and participants will receive QOL questionnaires which are already embedded within this cohort Therefore participants are not subjected to an additional burden during the course and follow-up period of this study In a recently published study there was no evidence that hypofractionation caused more GU andor GI grade 2 toxicity Radiobiologically the low alphabeta ratio of prostate cancer makes it more sensitive to higher doses of radiation in fewer fractions which is in fact the essence of the ultrahypofractionation scheme that we offer in the interventional arm
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