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Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy

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ClinicalTrials.gov Identifier: NCT03619655
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: SPECT CT Drug: 18F-DCFPyL PET/CT Drug: 18F-NaF PET/CT Procedure: WB-MRI Phase 1

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 15, 2023
Estimated Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: "Cohort A" - SPECT CT and NaF PET
Intervention 1: SPECT CT Intervention 2: NaF PET
Procedure: SPECT CT
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.

Drug: 18F-NaF PET/CT
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.
Other Names:
  • 18F-NaF
  • NaF PET

Experimental: "Cohort B" - SPECT CT and 18F-DCFPyL PET/CT
Intervention 1: SPECT CT Intervention 2: 18F-DCFPyL PET/CT
Procedure: SPECT CT
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.

Drug: 18F-DCFPyL PET/CT
A bolus of ~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.
Other Name: 18F-DCFPyL

Experimental: "Cohort C" - SPECT CT and WB-MRI
Intervention 1: SPECT CT Intervention 2: WB-MRI
Procedure: SPECT CT
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.

Procedure: WB-MRI
Whole body MRI exam (total examination time < 50 minutes)
Other Name: Whole body MRI




Primary Outcome Measures :
  1. Accuracy for Prediction of Progression Free Survival as determined by Quantitative bone SPECT indices (QBSIs) [ Time Frame: Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years ]
    QBSI will be measured on SPECT scans at pre-defined intervals. A lower QBSI would mean likelier progression free survival.


Secondary Outcome Measures :
  1. Reproducibility of the QBSIs using test-retest studies in 12 patients [ Time Frame: 5 years ]
    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.

  2. Ability of QBSPECT to detect recurrence of metastatic disease as determined by QBSI in 60 patients. [ Time Frame: Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years ]
    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.

  3. Accuracy of NaF PET/CT as determined by difference in QBSI from SPECT versus QBSI from NaF PET/CT in 20 patients [ Time Frame: Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years ]
    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.

  4. Accuracy of PSMA PET/CT as determined by difference in QBSI from SPECT versus QBSI from PSMA PET/CT in 20 patients [ Time Frame: Baseline, 6 months post-treatment, assessed up to 5 years ]
    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.

  5. Correlation of QBSI from SPECT/CT to restricted diffusion obtained from whole body MRI [ Time Frame: 5 years ]
    Ratio of QBSI obtained from SPECT imaging to quantitative biomarkers of restricted diffusion (diffusion-weighted imaging) obtained from a WB-MRI protocol.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

  1. PSA progression defined as 25% increase over baseline value or nadir.
  2. Radiographic progression for soft tissue lesions as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and/ or radiographic progression for bone lesions as determined by radionuclide bone scan using the consensus guidelines of the PCWG3 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619655


Contacts
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Contact: Rehab AbdAllah, MB BCh 443-287-1622 rabdall1@jhmi.edu
Contact: Lilja Solnes, MD

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Rehab AbdAllah    443-287-1622    rabdall1@jhmi.edu   
Principal Investigator: Lilja Solnes, M.D.         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lilja Solnes, MD Johns Hopkins University

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03619655     History of Changes
Other Study ID Numbers: J1835
IRB00165175 ( Other Identifier: JHM IRB )
U01CA140204 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
J1835
SPECT CT
PSMA
18F-DCFPyL PET/CT
WB-MRI
NaF
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases