Back to resultsMRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer
Primary Purpose
Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MRI-guided Intensity-Modulated Radiation Therapy
Antiandrogen Therapy
PSMA PET Scan
Computed Tomography
Magnetic Resonance Imaging
Bone Scan
Biospecimen Collection
Quality-of-Life Assessment
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: Age: above 18 years Participants must be histologically proven, adenocarcinoma prostate Localized to the prostate without positive pelvic lymph node involvement No distant metastatic disease assessed by pretreatment PSMA PET or bone scan and CT scan High risk prostate cancer as defined by National Comprehensive Cancer Network (NCCN): Gleason score of 8- 10, clinical stage T3a or higher, or prostate specific antigen (PSA) > 20 ng/mL Ability to receive long term hormone therapy Karnofsky performance score (KPS) > 70 No prior history of therapeutic irradiation to pelvis Patient willing and reliable for follow-up and quality of life (QOL) English speaking/reading Exclusion Criteria: Evidence of distant or pelvic metastasis at any time since presentation Life expectancy < 2 years Previous radiation therapy (RT) to prostate or prostatectomy A previous trans-urethral resection of the prostate (TURP) Severe urinary symptoms or with severe International Prostate Symptom Score (IPSS) score despite being on hormonal therapy for 6 months which in the opinion of the physician precludes RT Patients with known obstructive symptoms with stricture Any contraindication to radiotherapy such as inflammatory bowel disease
Sites / Locations
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (MRI-guided IMRT, ADT)
Arm Description
Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
Outcomes
Primary Outcome Measures
Rate of late grade 2+ genitourinary (GU) toxicity
Per Common Terminology Criteria for Adverse Events version 5.0 compared to rate of toxicity in POP-RT trial. Will be estimated for the entire sample that receives the intervention, treating death from any cause (other than treatment) as a competing risk and censoring subjects who drop out before experiencing toxicity at time of last follow-up. A point estimate of cumulative incidence at 1 year will be estimated from this curve along with a two-sided 90% confidence interval. If the upper bound of the interval is less than 20%, the null hypothesis will be rejected.
Secondary Outcome Measures
Incidence of acute GU and gastrointestinal (GI) toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Incidence of acute GU and gastrointestinal (GI) toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Incidence of acute GU and gastrointestinal (GI) toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Incidence of acute GU and gastrointestinal (GI) toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Incidence of late GI toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Incidence of late GI toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Incidence of late GI toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Incidence of late GI toxicity
Will be estimated using a binomial proportion and exact 95% confidence interval.
Overall survival
Will be estimated using the Kaplan-Meier method.
Overall survival
Will be estimated using the Kaplan-Meier method.
Overall survival
Will be estimated using the Kaplan-Meier method.
Overall survival
Will be estimated using the Kaplan-Meier method.
Prostate cancer specific survival
Will be estimated using the Kaplan-Meier method.
Prostate cancer specific survival
Will be estimated using the Kaplan-Meier method.
Prostate cancer specific survival
Will be estimated using the Kaplan-Meier method.
Prostate cancer specific survival
Will be estimated using the Kaplan-Meier method.
Biochemical failure
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Biochemical failure
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Biochemical failure
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Biochemical failure
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Quality of life measurement
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Quality of life measurement
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Quality of life measurement
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Quality of life measurement
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Full Information
NCT ID
NCT05676463
First Posted
December 13, 2022
Last Updated
October 12, 2023
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT05676463
Brief Title
MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer
Official Title
Phase 2 Study of Extreme Hypofractionation Including Pelvic Nodes for High Risk Prostate Cancer Using MgRT (MRI Guided Radiation Therapy)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
oh hold due to pause of outside company
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This phase II trial tests whether magnetic resonance imaging (MRI)-guided hypofractionated radiation therapy works to reduce treatment time and side effects in patients with high risk prostate cancer. MRI-guided hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time directly to diseased tissue, reducing damage to healthy tissue. Using MRI-guided radiation therapy on areas of the prostate and pelvic lymph nodes may shorten overall treatment time compared to the longer standard of care therapy and may reduce the number and/or duration of side effects.
Detailed Description
PRIMARY OBJECTIVE:
I. Evaluate late grade 2+ genitourinary (GU) toxicity.
SECONDARY OBJECTIVE:
I. Evaluating acute GU and gastrointestinal (GI) toxicity, late GI toxicity, overall survival, prostate cancer specific survival, biochemical failure, and quality of life.
OUTLINE:
Patients undergo MRI-guided intensity-modulated radiation therapy (IMRT) on study and receive standard of care (SOC) antiandrogen therapy (ADT) throughout the trial. Patients may also undergo prostate specific membrane antigen (PSMA) positron emission tomography (PET), computed tomography (CT), MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment (MRI-guided IMRT, ADT)
Arm Type
Experimental
Arm Description
Patients undergo MRI-guided IMRT on study and receive SOC ADT throughout the trial. Patients may also undergo PSMA PET, CT, MRI, and bone scans at screening and undergo collection of blood samples throughout the trial.
Intervention Type
Procedure
Intervention Name(s)
MRI-guided Intensity-Modulated Radiation Therapy
Intervention Description
Undergo MRI-guided IMRT
Intervention Type
Drug
Intervention Name(s)
Antiandrogen Therapy
Other Intervention Name(s)
ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy
Intervention Description
Receive SOC ADT
Intervention Type
Procedure
Intervention Name(s)
PSMA PET Scan
Other Intervention Name(s)
Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography
Intervention Description
Undergo PSMA PET scan
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized Tomography, CT, CT SCAN, tomography, Computerized axial tomography (procedure)
Intervention Description
Undergo CT
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, nuclear magnetic resonance imaging, Magnetic resonance imaging (procedure)
Intervention Description
Undergo MRI
Intervention Type
Procedure
Intervention Name(s)
Bone Scan
Other Intervention Name(s)
Bone Scintigraphy
Intervention Description
Undergo bone scan
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo blood sample collection
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Rate of late grade 2+ genitourinary (GU) toxicity
Description
Per Common Terminology Criteria for Adverse Events version 5.0 compared to rate of toxicity in POP-RT trial. Will be estimated for the entire sample that receives the intervention, treating death from any cause (other than treatment) as a competing risk and censoring subjects who drop out before experiencing toxicity at time of last follow-up. A point estimate of cumulative incidence at 1 year will be estimated from this curve along with a two-sided 90% confidence interval. If the upper bound of the interval is less than 20%, the null hypothesis will be rejected.
Time Frame
At 1 year
Secondary Outcome Measure Information:
Title
Incidence of acute GU and gastrointestinal (GI) toxicity
Description
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time Frame
At baseline
Title
Incidence of acute GU and gastrointestinal (GI) toxicity
Description
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time Frame
At treatment completion, up to 10 days
Title
Incidence of acute GU and gastrointestinal (GI) toxicity
Description
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time Frame
every 3 months after treatment until 1 year
Title
Incidence of acute GU and gastrointestinal (GI) toxicity
Description
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time Frame
every 6 months beginning at year 2, assessed up to 4 years
Title
Incidence of late GI toxicity
Description
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time Frame
At baseline
Title
Incidence of late GI toxicity
Description
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time Frame
At treatment completion, up to 10 days
Title
Incidence of late GI toxicity
Description
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time Frame
every 3 months after treatment until 1 year
Title
Incidence of late GI toxicity
Description
Will be estimated using a binomial proportion and exact 95% confidence interval.
Time Frame
every 6 months beginning at year 2, assessed up to 4 years
Title
Overall survival
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
At baseline
Title
Overall survival
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
At treatment completion, up to 10 days
Title
Overall survival
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
every 3 months after treatment until 1 year
Title
Overall survival
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
every 6 months beginning at year 2, assessed up to 4 years
Title
Prostate cancer specific survival
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
At baseline
Title
Prostate cancer specific survival
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
At treatment completion, up to 10 days
Title
Prostate cancer specific survival
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
every 3 months after treatment until 1 year
Title
Prostate cancer specific survival
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
every 6 months beginning at year 2, assessed up to 4 years
Title
Biochemical failure
Description
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Time Frame
At baseline
Title
Biochemical failure
Description
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Time Frame
At treatment completion, up to 10 days
Title
Biochemical failure
Description
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Time Frame
every 3 months after treatment until 1 year
Title
Biochemical failure
Description
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
Time Frame
every 6 months beginning at year 2, assessed up to 4 years
Title
Quality of life measurement
Description
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Time Frame
At baseline
Title
Quality of life measurement
Description
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Time Frame
At treatment completion, up to 10 days
Title
Quality of life measurement
Description
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Time Frame
every 3 months after treatment until 1 year
Title
Quality of life measurement
Description
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Time Frame
every 6 months beginning at year 2, assessed up to 4 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: above 18 years
Participants must be histologically proven, adenocarcinoma prostate
Localized to the prostate without positive pelvic lymph node involvement
No distant metastatic disease assessed by pretreatment PSMA PET or bone scan and CT scan
High risk prostate cancer as defined by National Comprehensive Cancer Network (NCCN): Gleason score of 8- 10, clinical stage T3a or higher, or prostate specific antigen (PSA) > 20 ng/mL
Ability to receive long term hormone therapy
Karnofsky performance score (KPS) > 70
No prior history of therapeutic irradiation to pelvis
Patient willing and reliable for follow-up and quality of life (QOL)
English speaking/reading
Exclusion Criteria:
Evidence of distant or pelvic metastasis at any time since presentation
Life expectancy < 2 years
Previous radiation therapy (RT) to prostate or prostatectomy
A previous trans-urethral resection of the prostate (TURP)
Severe urinary symptoms or with severe International Prostate Symptom Score (IPSS) score despite being on hormonal therapy for 6 months which in the opinion of the physician precludes RT
Patients with known obstructive symptoms with stricture
Any contraindication to radiotherapy such as inflammatory bowel disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Mueller, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer
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