An Investigational Scan (rh PSMA 7.3 PET/MRI) for the Detection of Recurrent Disease and Aid in Radiotherapy Planning in Biochemically Recurrent Prostate Cancer

NCT04978675 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 2020-1347NCI-2021-05725
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective pilot study will assess the feasibility of rh PSMA 7.3 positron emission tomography/magnetic resonance imaging (PET/MRI) scans in detecting prostate cancer that may have come back (recurrent) in patients with increasing levels of prostate-specific antigen (PSA) following prostate surgery (biochemically recurrent). An increase in PSA levels alone does not tell the doctor where the cancer may be or how much cancer there may be. Imaging tests, like a bone scan, MRI, and/or computed tomography, are often performed to help the doctor learn where or how much cancer there is, and how best to treat the cancer. rhPSMA-7.3 is a radioactive tracer agent that when used with PET/MRI imaging may help diagnose and look for the spread of prostate cancer. Prostate-specific membrane antigen (PSMA) is a protein that is expressed in prostate cancer and this agent targets the PSMA molecule. Giving rh PSMA 7.3 during PET/MRI may help doctors better find where the cancer may be spreading and how much of it there is. The results of this trial may also guide in radiotherapy planning.

Conditions

Biochemically Recurrent Prostate Carcinoma; Localized Prostate Carcinoma; Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Positive predictive value (PPV) of F-18 rhPSMA-7.3 positron emission tomography/magnetic resonance imaging (PET/MRI) in detecting recurrent disease

  Will be evaluated on both a per-patient and per-region basis. Will estimate the PPV rate and corresponding 95% confidence interval.

  Up to 6 months

Secondary Outcomes (2)

• Detection rate

  Up to 6 months

• Change in salvage radiation treatment plan

  Baseline up to 6 months

Study Arms (1)

Diagnostic (F-18 rhPSMA-7.3, PET/MRI)

EXPERIMENTAL

Patients receive F-18 rhPSMA-7.3 IV and after approximately 60 minutes of uptake time, will undergo PET/MRI over 60 minutes. Patients with evidence of F-18 rhPSMA-7.3 disease in the first PET/MRI scan undergo a second F-18 rhPSMA-7.3 PET/MRI at 6 months after the second dose of standard hormonal therapy.

Drug: Fluorine F 18 rhPSMA-7.3; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Interventions

Fluorine F 18 rhPSMA-7.3 DRUG

Given IV

Also known as: (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3, Fluorine F 18 radiohybrid PSMA-7.3, Fluorine-18 rhPSMA-7.3, rhPSMA-7.3 (18F)

Diagnostic (F-18 rhPSMA-7.3, PET/MRI)

Magnetic Resonance Imaging PROCEDURE

Undergo PET/MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Diagnostic (F-18 rhPSMA-7.3, PET/MRI)

Positron Emission Tomography PROCEDURE

Undergo PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Diagnostic (F-18 rhPSMA-7.3, PET/MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is male and aged \> 18 years old
• History of localized adenocarcinoma of the prostate status post (s/p) radical prostatectomy
• An initial elevated PSA \>= 0.2 followed by a subsequent confirmatory PSA \>= 0.2 clinically suspicious for biochemically recurrent disease
• If the patients were previously taking androgen deprivation therapy (ADT), it should be discontinued at least 12 weeks prior to the study
• Treatment plan includes salvage radiation with or without hormones.
• Patient willing to provide signed informed consent and willing to comply with all required study schedule events, where safe and feasible
• Non-English speaking patients may be enrolled.

You may not qualify if:

• Patients with any medical condition or circumstance that the investigator believes may compromise the data collected or lead to a failure to fulfil the study requirements
• Patients who are planned to have an Iodinated contrast agent with computed tomography (CT) or gadolinium based contrast agent with MRI or other PET radiotracer \< 24 hours prior to the PET scan
• Patients with contraindication to undergo MRI
• Patients with extreme claustrophobia
• Patients with prior allergy to MRI contrast agent
• Patients who are cognitively impaired

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Devaki Shilpa S Surasi

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 27, 2021
• Study Start: August 4, 2021
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: October 23, 2024

Record last verified: 2024-07

Locations

US (1)