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Radioactive Tracer Agent

rhPSMA 7.3 PET/MRI Scan for Recurrent Prostate Cancer

Phase 1
Recruiting
Led By Devaki Shilpa S Surasi
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is male and aged > 18 years old
Treatment plan includes salvage radiation with or without hormones
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study Summary

This trial will test whether a PET/MRI scan using a radioactive tracer agent can help detect recurrent prostate cancer in patients with increasing PSA levels following surgery.

Who is the study for?
This trial is for men over 18 with rising PSA levels after prostate surgery, suggesting recurrent cancer. They must have stopped hormone therapy at least 12 weeks before and be willing to follow the study plan. It's okay if they don't speak English, but they can't join if they have conditions affecting the study or are set to receive certain imaging agents within a day of the PET scan.Check my eligibility
What is being tested?
The trial tests an investigational PET/MRI scan using Fluorine F 18 rhPSMA-7.3 to detect recurring prostate cancer by targeting a protein common in these cells. This could improve locating and measuring cancer spread, aiding in planning radiotherapy treatments for patients.See study design
What are the potential side effects?
Potential side effects may include reactions related to the radioactive tracer agent (rhPSMA-7.3) such as rash or discomfort at injection site, and typical MRI-related issues like anxiety due to claustrophobia or allergic reactions to contrast agents used during imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man and older than 18.
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My treatment plan includes additional radiation, possibly with hormone therapy.
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I stopped my hormone therapy for cancer more than 12 weeks ago.
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I do not speak English but can join the trial.
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My PSA levels have been above 0.2 twice, indicating a possible cancer recurrence.
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I had surgery to remove my prostate due to cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Positive predictive value (PPV) of F-18 rhPSMA-7.3 positron emission tomography/magnetic resonance imaging (PET/MRI) in detecting recurrent disease
Secondary outcome measures
Change in salvage radiation treatment plan
Detection rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (F-18 rhPSMA-7.3, PET/MRI)Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Positron Emission Tomography
2008
Completed Phase 2
~2260

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,340 Total Patients Enrolled
96 Trials studying Prostate Cancer
29,740 Patients Enrolled for Prostate Cancer
Devaki Shilpa S SurasiPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Fluorine F 18 rhPSMA-7.3 (Radioactive Tracer Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04978675 — Phase 1
Prostate Cancer Research Study Groups: Diagnostic (F-18 rhPSMA-7.3, PET/MRI)
Prostate Cancer Clinical Trial 2023: Fluorine F 18 rhPSMA-7.3 Highlights & Side Effects. Trial Name: NCT04978675 — Phase 1
Fluorine F 18 rhPSMA-7.3 (Radioactive Tracer Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04978675 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants chosen to take part in this clinical trial?

"Affirmative. Evidence from clinicaltrials.gov confirm that this research trial, first published on August 4th 2021, is actively recruiting patients. 25 participants must be gathered from a singular site to complete the study's requirements."

Answered by AI

What hazards might be associated with Fluorine F 18 rhPSMA-7.3?

"As this is a Phase 1 trial, there is very little data available to support the safety and effectiveness of Fluorine F 18 rhPSMA-7.3; as such, it has been scored with a 1 on our scale from one to three."

Answered by AI

Have any other experimental tests included Fluorine F 18 rhPSMA-7.3?

"As of now, 8 clinical trials are being conducted to research the effects of Fluorine F 18 rhPSMA-7.3 with no Phase 3 studies in progress. The majority of these investigations take place in Honolulu, Hawaii although 33 other sites across America are offering this medication as part of their trial program."

Answered by AI

Are there any openings in this clinical trial at the current time?

"Data hosted on clinicaltrials.gov reveals that this medical research is currently recruiting volunteers. It was first posted on August 4th 2021 and most recently updated October 6 2022."

Answered by AI
~0 spots leftby Apr 2024