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

October 30, 2023 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Whole body MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years
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.
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
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.
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
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.
Baseline, 6 months post-treatment, assessed up to 5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lilja Solnes, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2019

Primary Completion (Actual)

November 14, 2022

Study Completion (Actual)

November 14, 2022

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

August 3, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J1835
  • IRB00165175 (Other Identifier: JHM IRB)
  • U01CA140204 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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