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

NCT ID: NCT03619655

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-15
• Study Completion Date: 2022-11-14

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

"Cohort A" - SPECT CT and NaF PET

Intervention 1: SPECT CT Intervention 2: NaF PET

Group Type: EXPERIMENTAL

SPECT CT

Intervention Type: 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.

18F-NaF PET/CT

Intervention Type: 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.

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

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

Group Type: EXPERIMENTAL

SPECT CT

Intervention Type: 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.

18F-DCFPyL PET/CT

Intervention Type: DRUG

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

"Cohort C" - SPECT CT and WB-MRI

Intervention 1: SPECT CT Intervention 2: WB-MRI

Group Type: EXPERIMENTAL

SPECT CT

Intervention Type: 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.

WB-MRI

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

18F-DCFPyL PET/CT

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

Intervention Type: 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.

Intervention Type: DRUG

WB-MRI

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

Intervention Type: PROCEDURE

Other Intervention Names

18F-DCFPyL; 18F-NaF; NaF PET; Whole body MRI

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lilja Solnes, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB00165175

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA140204

Identifier Type: NIH

Identifier Source: secondary_id

View Link

J1835

Identifier Type: -

Identifier Source: org_study_id