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

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SPECT CT

18F-DCFPyL PET/CT

18F-NaF PET/CT

WB-MRI

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring J1835, SPECT CT, PSMA, 18F-DCFPyL PET/CT, WB-MRI, NaF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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:

PSA progression defined as 25% increase over baseline value or nadir.
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.

Sites / Locations

Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

"Cohort A" - SPECT CT and NaF PET

"Cohort B" - SPECT CT and 18F-DCFPyL PET/CT

"Cohort C" - SPECT CT and WB-MRI

Arm Description

Intervention 1: SPECT CT Intervention 2: NaF PET

Intervention 1: SPECT CT Intervention 2: 18F-DCFPyL PET/CT

Intervention 1: SPECT CT Intervention 2: WB-MRI

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Ability of QBSPECT to detect recurrence of metastatic disease as determined by QBSI in 60 patients.

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.

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.

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.

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.

Full Information

NCT ID

NCT03619655

First Posted

August 3, 2018

Last Updated

January 9, 2023

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03619655

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

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.

Study Start Date

November 15, 2019 (Actual)

Primary Completion Date

November 14, 2022 (Actual)

Study Completion Date

November 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

J1835, SPECT CT, PSMA, 18F-DCFPyL PET/CT, WB-MRI, NaF

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

"Cohort A" - SPECT CT and NaF PET

Arm Type

Experimental

Arm Description

Intervention 1: SPECT CT Intervention 2: NaF PET

Arm Title

"Cohort B" - SPECT CT and 18F-DCFPyL PET/CT

Arm Type

Experimental

Arm Description

Intervention 1: SPECT CT Intervention 2: 18F-DCFPyL PET/CT

Arm Title

"Cohort C" - SPECT CT and WB-MRI

Arm Type

Experimental

Arm Description

Intervention 1: SPECT CT Intervention 2: WB-MRI

Intervention Type

Procedure

Intervention Name(s)

SPECT CT

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

18F-DCFPyL PET/CT

Other Intervention Name(s)

18F-DCFPyL

Intervention Description

A bolus of ~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.

Intervention Type

Drug

Intervention Name(s)

18F-NaF PET/CT

Other Intervention Name(s)

18F-NaF, NaF PET

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

WB-MRI

Other Intervention Name(s)

Whole body MRI

Intervention Description

Whole body MRI exam (total examination time < 50 minutes)

Primary Outcome Measure Information:

Title

Accuracy for Prediction of Progression Free Survival as determined by Quantitative bone SPECT indices (QBSIs)

Description

QBSI will be measured on SPECT scans at pre-defined intervals. A lower QBSI would mean likelier progression free survival.

Time Frame

Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years

Secondary Outcome Measure Information:

Title

Reproducibility of the QBSIs using test-retest studies in 12 patients

Description

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.

Time Frame

5 years

Title

Ability of QBSPECT to detect recurrence of metastatic disease as determined by QBSI in 60 patients.

Description

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.

Time Frame

Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years

Title

Accuracy of NaF PET/CT as determined by difference in QBSI from SPECT versus QBSI from NaF PET/CT in 20 patients

Description

Time Frame

Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years

Title

Accuracy of PSMA PET/CT as determined by difference in QBSI from SPECT versus QBSI from PSMA PET/CT in 20 patients

Description

Time Frame

Baseline, 6 months post-treatment, assessed up to 5 years

Title

Correlation of QBSI from SPECT/CT to restricted diffusion obtained from whole body MRI

Description

Ratio of QBSI obtained from SPECT imaging to quantitative biomarkers of restricted diffusion (diffusion-weighted imaging) obtained from a WB-MRI protocol.

Time Frame

5 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: PSA progression defined as 25% increase over baseline value or nadir. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lilja Solnes, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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