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PSMA-1007 PET/CT for Prostate Cancer

Phase 3

Waitlist Available

Research Sponsored by ABX advanced biochemical compounds GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Suspicion of recurrence or persistence after prostatectomy, PSA > 0.2 ng/mL on 2 or more determinations (recurrence), or failure of PSA to fall to undetectable levels post-prostatectomy (persistence) (American Urological Association)

Suspicion of recurrence or persistence after radiotherapy or cryotherapy: 3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir (ASTRO-Phoenix)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6 months after pet/ct

Awards & highlights

Study Summary

This trial looks at how well a PSMA-1007 PET/CT scan can detect prostate cancer recurrence in patients who have already had treatment for the disease.

Who is the study for?

Men with a history of prostate cancer treated previously, who now have signs their cancer might be back. They should expect to live at least another 6 months and be able to undergo all study procedures. Men under 18, those unable to have a PET/CT scan, or with allergies to the test drug can't join.Check my eligibility

What is being tested?

[18F]PSMA-1007 PET/CT is being tested for its ability to detect recurrent prostate cancer after initial treatment. The trial will assess how well this imaging technique works and monitor any safety issues that arise during the process.See study design

What are the potential side effects?

While specific side effects are not listed for [18F]PSMA-1007, typical PET/CT scans may cause discomfort at the injection site, allergic reactions, or anxiety about enclosed spaces during scanning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My PSA levels are above 0.2 ng/mL after prostate surgery, indicating possible cancer return or persistence.

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My PSA levels have been rising after treatment, indicating possible cancer return.

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I am a man who has been treated for prostate cancer before.

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I had surgery for prostate cancer and may need follow-up radiation, or I had radiation and my cancer is confirmed to be low volume.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6 months after pet/ct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 6 months after pet/ct

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 months after pet/ct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient-level correct detection rate of [18F]PSMA-1007

Region-level positive predictive value (PPV) of [18F]PSMA-1007 using a combined standard of truth (SOT)

Trial Design

1Treatment groups

Experimental Treatment

Group I: [18F]PSMA-1007Experimental Treatment1 Intervention

single intravenous administration of [18F]PSMA-1007 for Positron Emission Tomography (PET) scan

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

[18F]PSMA-1007

2017

N/A

~60

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

ABX advanced biochemical compounds GmbHLead Sponsor

5 Previous Clinical Trials

935 Total Patients Enrolled

4 Trials studying Prostate Cancer

885 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

What have been the adverse effects of [18F]PSMA-1007 on patients?

"[18F]PSMA-1007 is in Phase 3 clinical trials, so it has received a score of 3 for safety."

Answered by AI

Are investigators still looking for participants for this research?

"Yes, this trial is still open and recruiting patients according to the information provided on clinicaltrials.gov. The study was created on September 8th, 2021 and last updated less than a month ago on July 26th, 2022."

Answered by AI

How many patients are being enrolled in this research project?

"This study will require a total of 140 eligible patients in order to commence. The sponsor, ABX advanced biochemical compounds GmbH, plans to run the trial at various sites - two examples being Mayo Clinic (Rochester, Minnesota) and Huntsman Cancer Institute (Salt Lake City, Utah)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer

2021. "Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04742361.

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