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| ID | Type | Description | Link |
|---|---|---|---|
| JT 20770 | Other Identifier | JeffTrial Number |
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Loss of required MRI resources needed to conduct protocol-specified procedures
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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.
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.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for a total of 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (MRI-guided IMRT, ADT) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI-guided Intensity-Modulated Radiation Therapy | Procedure | Undergo MRI-guided IMRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute GU and gastrointestinal (GI) toxicity | Will be estimated using a binomial proportion and exact 95% confidence interval. | At baseline |
| Incidence of acute GU and gastrointestinal (GI) toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessie DiNome, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Antiandrogen Therapy | Drug | Receive SOC ADT |
|
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| PSMA PET Scan | Procedure | Undergo PSMA PET scan |
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| Computed Tomography | Procedure | Undergo CT |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
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| Bone Scan | Procedure | Undergo bone scan |
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| Biospecimen Collection | Procedure | Undergo blood sample collection |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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Will be estimated using a binomial proportion and exact 95% confidence interval.
| At treatment completion, up to 10 days |
| Incidence of acute GU and gastrointestinal (GI) toxicity | Will be estimated using a binomial proportion and exact 95% confidence interval. | every 3 months after treatment until 1 year |
| Incidence of acute GU and gastrointestinal (GI) toxicity | Will be estimated using a binomial proportion and exact 95% confidence interval. | every 6 months beginning at year 2, assessed up to 4 years |
| Incidence of late GI toxicity | Will be estimated using a binomial proportion and exact 95% confidence interval. | At baseline |
| Incidence of late GI toxicity | Will be estimated using a binomial proportion and exact 95% confidence interval. | At treatment completion, up to 10 days |
| Incidence of late GI toxicity | Will be estimated using a binomial proportion and exact 95% confidence interval. | every 3 months after treatment until 1 year |
| Incidence of late GI toxicity | Will be estimated using a binomial proportion and exact 95% confidence interval. | every 6 months beginning at year 2, assessed up to 4 years |
| Overall survival | Will be estimated using the Kaplan-Meier method. | At baseline |
| Overall survival | Will be estimated using the Kaplan-Meier method. | At treatment completion, up to 10 days |
| Overall survival | Will be estimated using the Kaplan-Meier method. | every 3 months after treatment until 1 year |
| Overall survival | Will be estimated using the Kaplan-Meier method. | every 6 months beginning at year 2, assessed up to 4 years |
| Prostate cancer specific survival | Will be estimated using the Kaplan-Meier method. | At baseline |
| Prostate cancer specific survival | Will be estimated using the Kaplan-Meier method. | At treatment completion, up to 10 days |
| Prostate cancer specific survival | Will be estimated using the Kaplan-Meier method. | every 3 months after treatment until 1 year |
| Prostate cancer specific survival | Will be estimated using the Kaplan-Meier method. | every 6 months beginning at year 2, assessed up to 4 years |
| Biochemical failure | Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method. | At baseline |
| Biochemical failure | Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method. | At treatment completion, up to 10 days |
| Biochemical failure | Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method. | every 3 months after treatment until 1 year |
| Biochemical failure | Defined as prostate specific antigen nadir plus 2 ng/ml. Will be estimated using the Kaplan-Meier method. | every 6 months beginning at year 2, assessed up to 4 years |
| Quality of life measurement | Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics. | At baseline |
| Quality of life measurement | Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics. | At treatment completion, up to 10 days |
| Quality of life measurement | Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics. | every 3 months after treatment until 1 year |
| Quality of life measurement | Using patient reported outcome-expanded prostate cancer index composite. Will be summarized using descriptive statistics. | every 6 months beginning at year 2, assessed up to 4 years |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000726 | Androgen Antagonists |
| D043425 | Glutamate Carboxypeptidase II |
| D009682 | Magnetic Resonance Spectroscopy |
| D014965 | X-Rays |
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002268 | Carboxypeptidases |
| D020689 | Exopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045727 | Metalloexopeptidases |
| D045726 | Metalloproteases |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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