Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205316
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-01-04
Brief Title:
SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Randomized Phase III Trial of SBRT Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This phase III trial tests the side effects of stereotactic body radiation therapy SBRT compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement recurrent or that has spread from where it first started primary site to a limited number of sites oligometastatic SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body except the brain The total dose of radiation is divided into smaller doses given over several days This type of radiation therapy helps spare normal tissue Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cells and have fewer side effects SBRT may work just as well as hypofractionated radiation therapy at treating patients with biochemically recurrent or oligometastatic prostate cancer but with a shorter treatment time and possibly fewer side effects
Detailed Description:
PRIMARY OBJECTIVE
I To determine if salvage SBRT is non-inferior to moderately hypofractionated radiation therapy regarding treatment related rates of genitourinary GU and gastrointestinal GI grade 3 or higher within 2-years
EXPLORATORY OBJECTIVES
I After completion of radiation therapy determine the incidence of
Ia Disease free survival DFS defined as the first occurrence of new clinical failure local recurrence regional recurrence or distant metastasis after salvage radiation therapy RT Ib Grade 2 or greater GU and GI toxicity at 3 years Common Terminology Criteria for Adverse Events CTCAE version 4 Ic Grade 3 or greater GU and GI toxicity at 3 years CTCAE version 4 Id Quality of life following completion of radiation therapy Ie Impotence after the use of radiation therapy at 3 years If Freedom from biochemical failure FFBF at 5 years Ig Local failure at 5 years Ih Regional failure at 5 years Ii Distant failure at 5 years Ij Salvage androgen deprivation therapy ADT use SAD at 5 years Ik Progression free survival using clinical biochemical and SAD as events at 5 years Il Overall survival at 5 years Im Disease-specific survival at 5 years II Determine the impact of salvage SBRT and hypofractionated radiation therapy HFRT on quality of life
III Determine prostate and normal structure movement during RT with the use of scans
IV Correlate pathologic and radiologic findings with outcomes V Correlate pre-RT prostate specific antigen PSA levels with outcomes VI Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity
VII Allow for future research of pathologic risk factors that may influence prognosis this information will help us to attempt to characterize their presence in prostate cancer with high-risk features after prostatectomy and their potential effect on outcomes
VIII Prospectively record contours that were manually drawn versus vs edited from artificial intelligence AI-generated contours
IX Determine the impact of using artificial intelligence AI tools for automatic segmenting prostate bed and other organs at risk in terms of toxicities and outcome
X Determine if there are any significant differences in dose-volumes results for cases that involved AI-autosegmentation vs cases without
XI Determine the relationship between the use of AI-autosegmentation tools with toxicities and outcome
XII Different online daily imaging guidance systems are allowed in this trial including x-rays conventional Feldkamp-Davis-Kress FDK-based cone beam computed tomography CBCT and iterative CBCT Subgroup analysis will be performed to determine patient alignment accuracy and toxicities rates with respect to different online daily imaging systems
OUTLINE Patients are randomized to 1 of 2 groups
GROUP I Patients undergo SBRT over 15-20 minutes every other day for a total of 5 treatments over 1-2 weeks in the absence of disease progression or unacceptable toxicity Patients may receive androgen deprivation therapy for up to 18 months as clinically indicated Patients undergo bone scan and positron emission tomography PET at screening and treatment failure and undergo magnetic resonance imaging MRI and blood sample collection throughout the study
GROUP II Patients undergo hypofractionated radiation therapy over 15-20 minutes once per day for a total of 20 treatments over 4-6 weeks in the absence of disease progression or unacceptable toxicity Patients may receive androgen deprivation therapy for up to 18 months as clinically indicated Patients undergo bone scan and PET at screening and treatment failure and undergo MRI and blood sample collection throughout the study
After completion of study treatment patients follow up at 3 months 12 months annually until year 5 and then every other year until death
I To determine if salvage SBRT is non-inferior to moderately hypofractionated radiation therapy regarding treatment related rates of genitourinary GU and gastrointestinal GI grade 3 or higher within 2-years
EXPLORATORY OBJECTIVES
I After completion of radiation therapy determine the incidence of
Ia Disease free survival DFS defined as the first occurrence of new clinical failure local recurrence regional recurrence or distant metastasis after salvage radiation therapy RT Ib Grade 2 or greater GU and GI toxicity at 3 years Common Terminology Criteria for Adverse Events CTCAE version 4 Ic Grade 3 or greater GU and GI toxicity at 3 years CTCAE version 4 Id Quality of life following completion of radiation therapy Ie Impotence after the use of radiation therapy at 3 years If Freedom from biochemical failure FFBF at 5 years Ig Local failure at 5 years Ih Regional failure at 5 years Ii Distant failure at 5 years Ij Salvage androgen deprivation therapy ADT use SAD at 5 years Ik Progression free survival using clinical biochemical and SAD as events at 5 years Il Overall survival at 5 years Im Disease-specific survival at 5 years II Determine the impact of salvage SBRT and hypofractionated radiation therapy HFRT on quality of life
III Determine prostate and normal structure movement during RT with the use of scans
IV Correlate pathologic and radiologic findings with outcomes V Correlate pre-RT prostate specific antigen PSA levels with outcomes VI Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity
VII Allow for future research of pathologic risk factors that may influence prognosis this information will help us to attempt to characterize their presence in prostate cancer with high-risk features after prostatectomy and their potential effect on outcomes
VIII Prospectively record contours that were manually drawn versus vs edited from artificial intelligence AI-generated contours
IX Determine the impact of using artificial intelligence AI tools for automatic segmenting prostate bed and other organs at risk in terms of toxicities and outcome
X Determine if there are any significant differences in dose-volumes results for cases that involved AI-autosegmentation vs cases without
XI Determine the relationship between the use of AI-autosegmentation tools with toxicities and outcome
XII Different online daily imaging guidance systems are allowed in this trial including x-rays conventional Feldkamp-Davis-Kress FDK-based cone beam computed tomography CBCT and iterative CBCT Subgroup analysis will be performed to determine patient alignment accuracy and toxicities rates with respect to different online daily imaging systems
OUTLINE Patients are randomized to 1 of 2 groups
GROUP I Patients undergo SBRT over 15-20 minutes every other day for a total of 5 treatments over 1-2 weeks in the absence of disease progression or unacceptable toxicity Patients may receive androgen deprivation therapy for up to 18 months as clinically indicated Patients undergo bone scan and positron emission tomography PET at screening and treatment failure and undergo magnetic resonance imaging MRI and blood sample collection throughout the study
GROUP II Patients undergo hypofractionated radiation therapy over 15-20 minutes once per day for a total of 20 treatments over 4-6 weeks in the absence of disease progression or unacceptable toxicity Patients may receive androgen deprivation therapy for up to 18 months as clinically indicated Patients undergo bone scan and PET at screening and treatment failure and undergo MRI and blood sample collection throughout the study
After completion of study treatment patients follow up at 3 months 12 months annually until year 5 and then every other year until death
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-10897 | REGISTRY | None | None |
| 22-009244 | OTHER | None | None |
| GMROA2255 | OTHER | Mayo Clinic in Arizona | None |