What side effects are associated with this type of intervention?

Common treatments for urethral cancer, particularly those involving radiotracers and PET imaging like 64 Cu-GRIP B, may include side effects such as mild to moderate fatigue, nausea, and localized pain at the injection site. Immunotherapy, often used in conjunction with these treatments, can lead to side effects like chills, fever, fatigue, and joint pain. Radiotherapy, another common treatment, may cause skin irritation, urinary symptoms, and gastrointestinal discomfort. These side effects are generally manageable and transient, but patients should discuss potential risks and benefits with their healthcare provider.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for urethral cancer in the provided context. However, for genitourinary malignancies, advanced imaging techniques such as the use of radiotracers targeting specific biomarkers are being studied. The 64Cu-GRIP B trial, for instance, evaluates a radiotracer targeting granzyme B for PET imaging to detect immune response in advanced cancers. Similar approaches in imaging and treatment include the use of 68Ga-labeled PSMA agents for prostate cancer and 68Ga-NeoBOMB1 for GRPR-expressing tumors, which highlight the potential of radiotracers in cancer detection and monitoring.

What other types of research exist?

Promising alternatives to 64Cu-GRIP B for PET imaging in urethral cancer patients include: 1) 18F-Fluoride PET, which has been effective in assessing metastatic bone tumors; 2) 68Ga-DOTATATE PET/CT, used for neuroendocrine tumors but potentially applicable for other cancers; and 3) 177Lu-PSMA-617, which has shown efficacy in prostate cancer and could be explored for urethral cancer. These alternatives offer advanced imaging capabilities and may help in monitoring treatment response.

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64Cu-GRIP B PET Imaging for Genitourinary Cancer

Phase 1 & 2

Recruiting

Led By Rahul Aggarwal, MD

Research Sponsored by Rahul Aggarwal

Eligibility Criteria Checklist

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

Must have

Age 18 years or older at the time of study entry

Histologically-confirmed metastatic renal cell carcinoma (any histologic sub-type) or urothelial carcinoma with locally advanced or metastatic disease on conventional imaging (Cohort B)

Must not have

Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special imaging technique to help see how well the immune system is fighting advanced GU cancers. It targets patients with specific types of advanced cancers and works by highlighting areas where immune cells are attacking cancer cells. This can help predict how well treatments are working.

Who is the study for?

This trial is for adults with advanced genitourinary cancers, such as kidney and urethral cancer. Participants must be over 18, not pregnant or breastfeeding, willing to use contraception, and have a good performance status (able to carry out daily activities). They should have adequate organ function and specific types of metastatic cancer confirmed by tests.

What is being tested?

The study is testing a new imaging technique using Copper-64 labeled Granzyme B (64Cu-GRIP B) with PET scans in patients with advanced genitourinary malignancies. It aims to identify tumors that may respond well to immunotherapy based on the presence of certain immune cells within the tumor.

What are the potential side effects?

As this is an imaging study primarily focused on detecting granzyme B in tumors using PET scans, direct side effects from the tracer are not extensively detailed but could include reactions at the injection site or allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My kidney or urinary cancer has spread and this is confirmed by tests.

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My kidney, liver, and blood counts are within the required ranges.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer has spread and this was confirmed by tests.

Exclusion Criteria

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

Select...

I am unable to give informed consent due to my age, health, or mental condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

AUC extrapolated to infinity (Cohort A)

Apparent terminal elimination half-life (Cohort A)

Apparent terminal elimination rate constant (Cohort A)

+8 more

Secondary study objectives

Association of baseline uptake with object response (ORR) (Cohorts B, C and D)

Association of baseline uptake with progression-free survival (PFS) (Cohorts B, C and D)

Association of baseline uptake with reported PSA50 response (Cohort C)

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort D: 64Cu-GRIP B, Advanced malignanciesExperimental Treatment2 Interventions

participants with solid tumor malignancies will have longitudinal imaging performed prior to treatment outside of this study, 8 weeks following initiation of treatment, and the opportunity to have an optional scan at the time of progression.

Group II: Cohort C: 64Cu-GRIP B, mCRPC participantsExperimental Treatment2 Interventions

Participants with metastatic castration resistant prostate cancer (mCRPC)) will have longitudinal imaging performed prior to treatment outside of this study, 8 weeks following initiation of treatment outside of this study, and at the time of disease progression by Prostate Cancer Working Group 3 (PCWG3) criteria.

Group III: Cohort B: 64Cu-GRIP B, RCC and UC participantsExperimental Treatment2 Interventions

Participants with renal cell and urothelial carcinoma will have longitudinal imaging performed prior to treatment outside of this study with anti-programmed death-1 (PD-1)/anti-PD-1 ligand 1 (PD-L1) blockade (with or without concomitant anti-CTLA4 treatment), after 8 weeks of checkpoint blockade, and again at the time of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Group IV: Cohort A: 64Cu-GRIP B, Metastatic GU malignanciesExperimental Treatment2 Interventions

Participants with metastatic GU malignancy (renal, urothelial, or prostate) (3 males, 3 females), dosimetry calculation will be performed by obtaining whole body (vertex to thighs) PET images up to five time points from 0.5 to 24 hours post 64Cu-GRIP B injections. An additional intravenous line will be placed in the contra-lateral arm to collect blood for this group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography (PET)

2018

Completed Phase 4

~1540

0 / 6Eligibility 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

The most common treatments for urethral cancer include immunotherapies, chemotherapy, and radiotherapy. Immunotherapies, such as immune checkpoint inhibitors (e.g., pembrolizumab, atezolizumab), work by enhancing the body's immune response against cancer cells. These therapies block proteins that inhibit immune cells, thereby allowing the immune system to attack the cancer more effectively. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while radiotherapy uses high-energy radiation to destroy cancer cells. The 64Cu-GRIP B trial focuses on using a radiotracer to detect granzyme B, a biomarker indicating immune cell activity in response to immunotherapy. This is crucial for urethral cancer patients as it helps identify tumors that are more likely to respond to immunotherapy, allowing for more personalized and effective treatment plans.

Gamma glutamyl transpeptidase activity in rat urothelium treated with bladder carcinogens.Genitourinary tumours in the targeted therapies era: new advances in clinical practice and future perspectives.Cyclooxygenase-2 (COX-2) up-regulation is a prognostic marker for poor clinical outcome of upper tract urothelial cancer.