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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00165175 | Other Identifier | JHM IRB | |
| U01CA140204 | U.S. NIH Grant/Contract | View source |
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Due to changing prostate cancer standard of care, the research question became obsolete as the target population for the study no longer existed. The study is deemed not clinically relevant.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT.
The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT. The study will consist of 3 cohorts, and a subset of the patients in cohort C will participate in a test-retest study, where the baseline SPECT/CT will be repeated.
SPECT CT will be performed in all cohorts.
Cohort A will evaluate SPECT CT by comparison to a Positron Emission Tomography (PET) scan using NaF.
Cohort B will evaluate SPECT CT by comparison to 18F-DCFPyL PET/CT.
Cohort C will evaluate SPECT CT by comparison to Whole Body Magnetic Resonance Imaging (WB-MRI).
Eligible subjects will be enrolled in a non-randomized manner per the treating physician discretion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Cohort A" - SPECT CT and NaF PET | Experimental | Intervention 1: SPECT CT Intervention 2: NaF PET |
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| "Cohort B" - SPECT CT and 18F-DCFPyL PET/CT | Experimental | Intervention 1: SPECT CT Intervention 2: 18F-DCFPyL PET/CT |
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| "Cohort C" - SPECT CT and WB-MRI | Experimental | Intervention 1: SPECT CT Intervention 2: WB-MRI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPECT CT | Procedure | MDP (99mTc-MDP) administration, about 180 min post-injection: whole body scan followed by a SPECT CT of regions designated by a board certified Nuclear Medicine physician after review of the whole body scan. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy for Prediction of Progression Free Survival as determined by Quantitative bone SPECT indices (QBSIs) | QBSI will be measured on SPECT scans at pre-defined intervals. A lower QBSI would mean likelier progression free survival. | Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of the QBSIs using test-retest studies in 12 patients | Reproducibility measured by difference in QBSI between test-retest in 12 patients, as defined by the protocol. A smaller difference in QBSI reflects greater reproducibility. | 5 years |
| Ability of QBSPECT to detect recurrence of metastatic disease as determined by QBSI in 60 patients. |
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Inclusion Criteria:
Males ≥18 years of age. Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
Histologically confirmed adenocarcinoma of the prostate. Metastatic castration-resistant prostate cancer (mCRPC) with Bone metastases as manifested by one or more lesions on bone scan.
Documented castrate level of serum testosterone (≤50 ng/dl).
Documented progressive mCRPC based on at least one of the following criteria:
Planning to receive first line novel hormonal therapy with Abiraterone or Enzalutamide for the first time for mCRPC within 4 weeks of documented progression. Baseline scans will be obtained prior to starting new therapy.
Exclusion Criteria:
Subjects who are unable to give valid informed consent Subjects who are unwilling or unable to undergo an SPECT, PET or MR exam, including subjects with contra-indications to MR exams.
Subjects with prior Enzalutamide and Abiraterone for mCRPC Subjects with prior taxane chemotherapy for mCRPC Subjects administered any radioisotope within five physical half-lives or any IV X-ray contrast medium within 24 hours or any high density oral contrast medium (oral water contrast is acceptable) within 5 days prior to study drug injection.
Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
Patients with a history reaction to gadolinium contrast agent. For cohort C, patients with renal failure (eGFR < 60ml/min/1.73m2) or patients on dialysis.
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| Name | Affiliation | Role |
|---|---|---|
| Lilja Solnes, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States | ||
| Thomas Jefferson University |
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| 18F-DCFPyL PET/CT | Drug | A bolus of ~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push. |
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| 18F-NaF PET/CT | Drug | A dose of 5 mCi 18F-NaF is injected through the IV and followed by at least 10 ml of saline to flush the IV line of the remaining dose. At the 1 hour post injection time, total Whole Body Images take approximately 40 - 60 minutes depending on the height of the patient. |
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| WB-MRI | Procedure | Whole body MRI exam (total examination time < 50 minutes) |
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QBSI will be measured on QBSPECT images obtained at the same time as standard-of-care bone scans. A higher QBSI would predict earlier recurrence of metastasis. |
| Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years |
| Accuracy of NaF PET/CT as determined by difference in QBSI from SPECT versus QBSI from NaF PET/CT in 20 patients | Difference in QBSI from SPECT versus NaF PET/CT. A smaller difference in the measured QBSI would reflect a higher accuracy of Na18F PET/CT. These images will be acquired within 32 hours of the bone scintigraphy scans at the pre-defined time points, per protocol. | Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years |
| Accuracy of PSMA PET/CT as determined by difference in QBSI from SPECT versus QBSI from PSMA PET/CT in 20 patients | Difference in QBSI from SPECT versus PSMA PET/CT. A smaller difference in the measured QBSI would reflect a higher accuracy of PSMA PET/CT. These images will be acquired within 32 hours of the bone scintigraphy scans at the pre-defined time points, per protocol. | Baseline, 6 months post-treatment, assessed up to 5 years |
| Correlation of QBSI from SPECT/CT to restricted diffusion obtained from whole body MRI | Ratio of QBSI obtained from SPECT imaging to quantitative biomarkers of restricted diffusion (diffusion-weighted imaging) obtained from a WB-MRI protocol. | 5 years |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| 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 |
|---|---|
| C572626 | 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid |
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