What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including those involving PSMA-targeted imaging like 18F-PSMA-1007 PET/CT, can have various side effects. PSMA-targeted therapies and imaging are generally well-tolerated but can cause dry mouth and mild bone marrow suppression. Androgen deprivation therapy (ADT) often leads to hot flashes, decreased libido, and increased risk of cardiovascular issues. Radiotherapy can result in urinary and bowel dysfunction, fatigue, and skin irritation. Chemotherapy, such as docetaxel, may cause nausea, hair loss, and increased risk of infections due to lowered blood cell counts. It is important to discuss these potential side effects with a healthcare provider to make an informed treatment decision.

What prior FDA approvals exist?

The FDA has approved several PSMA-targeted therapies for prostate cancer, enhancing both imaging and treatment. Notably, lutetium Lu 177 vipivotide tetraxetan (Lu-PSMA-617) has been approved for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) following prior treatment with androgen receptor pathway inhibitors and taxane-based chemotherapy. This radioligand therapy significantly improves radiographic progression-free survival and overall survival. Additionally, PSMA-targeted PET imaging agents like 68Ga-PSMA-11 have been approved for detecting prostate cancer recurrence, aiding in precise treatment planning.

What other types of research exist?

Promising alternatives to 18F-PSMA-1007 PET/CT imaging for prostate cancer patients include 89Zr-PSMA-617 PET/CT, which has shown potential in identifying local recurrences not detected by 68Ga-PSMA-11 PET/CT. Additionally, 68Ga-PSMA PET/CT is another viable option, particularly for identifying patients eligible for treatment with 177Lu-PSMA-617. These alternatives offer enhanced imaging capabilities and may provide better diagnostic accuracy in certain clinical scenarios.

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Diagnostic Test

18F-PSMA-1007 PET/CT Imaging for Prostate Cancer

Phase 2

Waitlist Available

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Adult patients (≥ 18 years old) with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 µg/L (minimum two samples) OR a serum PSA doubling-time of < 9 months

Adult patients (≥ 18 years old) with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score > 7, serum PSA > 20 µg/L, OR minimum clinical T-stage T2c.

Must not have

Unable to lie flat for 30 minutes to complete the PET-CT imaging session

Weight >225 kg (weight limitation of PET/CT scanner)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately (within 15 minutes) after 18f-psma-1007 injection

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special scan to detect prostate cancer cells in adults who have been treated for prostate cancer or are at high risk of it spreading. The scan works by using a radioactive substance that highlights cancer cells, making them visible on the scan.

Who is the study for?

This trial is for adult men with prostate cancer who've had treatments like radiotherapy or surgery, and now have rising PSA levels or high-risk features. They must be able to consent, lie flat for the scan, and not exceed the PET/CT scanner's weight limit.

What is being tested?

The study tests a new imaging method using 18F-PSMA-1007 PET/CT scans in patients with recurrent or high-risk prostate cancer. It aims to evaluate safety, how the body processes it, its effectiveness in detecting cancer compared to standard bone and CT scans.

What are the potential side effects?

Potential side effects may include allergic reactions specific to the imaging agent used (18F-PSMA-1007). However, since this is an imaging study rather than a drug treatment trial, fewer side effects are expected.

Eligibility Criteria

Inclusion Criteria

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

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I am an adult who has had prostate cancer treatment and my PSA is rising or doubling quickly.

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I am an adult with prostate cancer, high Gleason score, PSA > 20, or T-stage T2c or higher.

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I am over 18, had prostate surgery, and my PSA level is above 0.2 µg/L.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot lie flat for 30 minutes.

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My weight is under 225 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately (within 15 minutes) after 18f-psma-1007 injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately (within 15 minutes) after 18f-psma-1007 injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately (within 15 minutes) after 18f-psma-1007 injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biodistribution

Diagnostic Accuracy

Safety - delayed

+2 more

Secondary study objectives

Clinical Efficacy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 18F-PSMA-1007 PET/CT scanExperimental Treatment1 Intervention

Single Arm study - all enrolled patients will undergo an experimental 18F-PSMA-1007 PET/CT scan

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-PSMA-1007

2021

Completed Phase 2

~100

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Prostate cancer treatments often target specific mechanisms to inhibit cancer growth and spread. One common approach involves targeting the prostate-specific membrane antigen (PSMA), a protein highly expressed on prostate cancer cells. Radiotracers like 18F-PSMA-1007 bind to PSMA, allowing for enhanced imaging and precise localization of cancerous tissues. This aids in accurate diagnosis and staging, which is crucial for effective treatment planning. Additionally, treatments such as androgen deprivation therapy (ADT) reduce levels of male hormones that fuel cancer growth, while newer agents like enzalutamide block androgen receptors directly. These targeted therapies are essential as they offer more personalized and effective treatment options, improving outcomes and quality of life for prostate cancer patients.

Resistance to prostate cancer treatments.Considerations on Integrating Prostate-Specific Membrane Antigen Positron Emission Tomography Imaging Into Clinical Prostate Cancer Trials by National Clinical Trials Network Cooperative Groups.Focal therapy for localized prostate cancer in the era of routine multi-parametric MRI.