Study 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.
Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy
3 other identifiers
interventional
3
1 country
2
Brief Summary
The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 prostate-cancer
Started Nov 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2018
CompletedFirst Posted
Study publicly available on registry
August 8, 2018
CompletedStudy Start
First participant enrolled
November 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2022
CompletedOctober 31, 2023
October 1, 2023
3 years
August 3, 2018
October 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Reproducibility of the QBSIs using test-retest studies in 12 patients
5 years
Ability of QBSPECT to detect recurrence of metastatic disease as determined by QBSI in 60 patients.
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
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
Baseline, 6 months post-treatment, assessed up to 5 years
Correlation of QBSI from SPECT/CT to restricted diffusion obtained from whole body MRI
5 years
Study Arms (3)
"Cohort A" - SPECT CT and NaF PET
EXPERIMENTALIntervention 1: SPECT CT Intervention 2: NaF PET
"Cohort B" - SPECT CT and 18F-DCFPyL PET/CT
EXPERIMENTALIntervention 1: SPECT CT Intervention 2: 18F-DCFPyL PET/CT
"Cohort C" - SPECT CT and WB-MRI
EXPERIMENTALIntervention 1: SPECT CT Intervention 2: WB-MRI
Interventions
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.
A bolus of \~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.
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.
Whole body MRI exam (total examination time \< 50 minutes)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lilja Solnes, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2018
First Posted
August 8, 2018
Study Start
November 15, 2019
Primary Completion
November 14, 2022
Study Completion
November 14, 2022
Last Updated
October 31, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share