MRI Guided Radiation Therapy for the Treatment of High Risk Prostate Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVE:
- Evaluate late grade 2+ genitourinary (GU) toxicity.
SECONDARY OBJECTIVE:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (MRI-guided IMRT, ADT) 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. |
Procedure: MRI-guided Intensity-Modulated Radiation Therapy
Undergo MRI-guided IMRT
Drug: Antiandrogen Therapy
Receive SOC ADT
Other Names:
Procedure: PSMA PET Scan
Undergo PSMA PET scan
Other Names:
Procedure: Computed Tomography
Undergo CT
Other Names:
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
Procedure: Bone Scan
Undergo bone scan
Other Names:
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Rate of late grade 2+ genitourinary (GU) toxicity [At 1 year]
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 [At baseline]
Will be estimated using a binomial proportion and exact 95% confidence interval.
- Incidence of acute GU and gastrointestinal (GI) toxicity [At treatment completion, up to 10 days]
Will be estimated using a binomial proportion and exact 95% confidence interval.
- Incidence of acute GU and gastrointestinal (GI) toxicity [every 3 months after treatment until 1 year]
Will be estimated using a binomial proportion and exact 95% confidence interval.
- Incidence of acute GU and gastrointestinal (GI) toxicity [every 6 months beginning at year 2, assessed up to 4 years]
Will be estimated using a binomial proportion and exact 95% confidence interval.
- Incidence of late GI toxicity [At baseline]
Will be estimated using a binomial proportion and exact 95% confidence interval.
- Incidence of late GI toxicity [At treatment completion, up to 10 days]
Will be estimated using a binomial proportion and exact 95% confidence interval.
- Incidence of late GI toxicity [every 3 months after treatment until 1 year]
Will be estimated using a binomial proportion and exact 95% confidence interval.
- Incidence of late GI toxicity [every 6 months beginning at year 2, assessed up to 4 years]
Will be estimated using a binomial proportion and exact 95% confidence interval.
- Overall survival [At baseline]
Will be estimated using the Kaplan-Meier method.
- Overall survival [At treatment completion, up to 10 days]
Will be estimated using the Kaplan-Meier method.
- Overall survival [every 3 months after treatment until 1 year]
Will be estimated using the Kaplan-Meier method.
- Overall survival [every 6 months beginning at year 2, assessed up to 4 years]
Will be estimated using the Kaplan-Meier method.
- Prostate cancer specific survival [At baseline]
Will be estimated using the Kaplan-Meier method.
- Prostate cancer specific survival [At treatment completion, up to 10 days]
Will be estimated using the Kaplan-Meier method.
- Prostate cancer specific survival [every 3 months after treatment until 1 year]
Will be estimated using the Kaplan-Meier method.
- Prostate cancer specific survival [every 6 months beginning at year 2, assessed up to 4 years]
Will be estimated using the Kaplan-Meier method.
- Biochemical failure [At baseline]
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
- Biochemical failure [At treatment completion, up to 10 days]
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
- Biochemical failure [every 3 months after treatment until 1 year]
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
- Biochemical failure [every 6 months beginning at year 2, assessed up to 4 years]
Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method.
- Quality of life measurement [At baseline]
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
- Quality of life measurement [At treatment completion, up to 10 days]
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
- Quality of life measurement [every 3 months after treatment until 1 year]
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
- Quality of life measurement [every 6 months beginning at year 2, assessed up to 4 years]
Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Thomas Jefferson University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22D.687