68Ga-PSMA-11 PET Scan for Prostate Cancer

Overseen By Akshata Mathur

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Washington

Must be taking: Androgen inhibitors, Chemotherapy

Disqualifiers: Active infection, Heart failure, Angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

213 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of a new scan, the 68Ga-PSMA-11 PET scan, for imaging prostate cancer. It aims to improve the detection and diagnosis of prostate cancer and monitor patient responses to treatments. This trial suits individuals with prostate cancer, particularly those with high PSA levels that continue to rise after treatment or with a type of prostate cancer that has spread and does not respond to hormone treatment. Participants will receive a special imaging agent (Gallium Ga 68 Gozetotide) and undergo scans to assess cancer behavior. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in prostate cancer imaging.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the 68Ga-PSMA-11 PET scan is safe for imaging prostate cancer?

Research has shown that Gallium Ga 68 Gozetotide aids in detecting prostate cancer through PET scans. Studies have found it generally safe, with most patients experiencing no serious side effects. Some individuals might have mild reactions like nausea or headache, but these are uncommon.

The FDA has approved Gallium Ga 68 Gozetotide for specific uses in prostate cancer imaging, indicating it has passed safety checks for those applications. While considered safe, it is still under study for other uses. Patients should consult their healthcare provider to understand its implications for their situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard imaging techniques for prostate cancer, Gallium Ga 68-labeled PSMA-11 offers a novel approach by targeting a specific protein found on prostate cancer cells called PSMA (Prostate-Specific Membrane Antigen). This makes it highly effective in detecting cancer spread with more precision. Researchers are enthusiastic about this treatment because it uses a radioactive tracer that binds directly to PSMA, providing clearer and more detailed images than conventional scans. This could lead to earlier and more accurate detection of prostate cancer, ultimately improving patient outcomes by tailoring treatment plans more effectively.

What evidence suggests that the 68Ga-PSMA-11 PET scan is effective for imaging prostate cancer?

Research has shown that the 68Ga-PSMA-11 PET scan, which participants in this trial will undergo, effectively detects prostate cancer. Studies indicate that this scan can accurately identify the stage of prostate cancer at its initial appearance. The success rate of this method ranges from 63% to 75%. This accuracy aids doctors in early cancer detection and in selecting the best treatment plan. Early detection with this scan can guide treatment decisions, potentially improving outcomes for patients with prostate cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Delphine Chen, MD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

Men with prostate cancer who have had surgery or radiation therapy and show signs of the cancer returning, as indicated by rising PSA levels. They must not have other cancers within the last 2 years (with some exceptions) and should be in a stable physical condition with a performance status indicating they can carry out daily activities without significant limitations.

Inclusion Criteria

My PSA levels are above 0.2 ng/mL after prostate surgery, indicating a recurrence.

My prostate cancer has spread and is not responding to hormone therapy.

I haven't had any cancer except for certain skin, bladder cancers, or very early stage leukemia in the past 2 years.

Exclusion Criteria

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Imaging

Patients receive gallium Ga 68-labeled PSMA-11 intravenously and undergo PET/CT or PET/MR scan

1 day

1 visit (in-person)

Follow-up Imaging

Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy

12 weeks

1 visit (in-person)

Long-term Follow-up

Patients are monitored for safety and effectiveness after treatment completion at 60 days, 6 months, and annually up to 5 years or until time of first progression

5 years

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Gallium Ga 68 Gozetotide

Trial Overview The trial is testing how effective a new type of PET scan called 68Ga-PSMA-11 is at detecting prostate cancer compared to standard imaging techniques. It aims to improve diagnosis and monitoring of treatment response in patients showing signs of recurrent prostate cancer.

How Is the Trial Designed?

Group I: Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR) Experimental Treatment 6 Interventions

Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

[68Ga]Ga-PSMA-11 is a key radiopharmaceutical used for imaging prostate-specific membrane antigen (PSMA), which is crucial for managing recurrent prostate cancer.

The paper provides a comprehensive overview of the preclinical development and clinical applications of [68Ga]Ga-PSMA-11, comparing its effectiveness with other imaging methods to guide clinicians in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[68Ga]Ga-PSMA-11 in prostate cancer: a comprehensive review. Bois, F., Noirot, C., Dietemann, S., et al.[2020]

Gallium-68 can be effectively used to radiolabel high-affinity inhibitors of prostate-specific membrane antigen (PSMA), achieving high yields (60-70%) and excellent purity (>99%).

The compounds [(68)Ga]3 and [(68)Ga]6 demonstrated significant tumor uptake in PSMA+ tumors, with clear delineation of tumors in PET imaging, indicating their potential for precise cancer imaging without the need for a cyclotron.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-labeled inhibitors of prostate-specific membrane antigen (PSMA) for imaging prostate cancer. Banerjee, SR., Pullambhatla, M., Byun, Y., et al.[2022]

The 68Ga-PSMA-11 PET/CT imaging technique demonstrated a detection rate of 53.6% for identifying prostate cancer relapse in 332 patients, with varying effectiveness based on the clinical stage of biochemical recurrence (BCR).

The positive predictive value (PPV) of 68Ga-PSMA-11 PET/CT was very high at 96.2%, indicating its reliability in detecting local versus systemic disease in patients with rising PSA levels after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 PET/CT in recurrent prostate cancer: efficacy in different clinical stages of PSA failure after radical therapy. Ceci, F., Castellucci, P., Graziani, T., et al.[2021]

99mTechnetium labeled PSMA SPECT-CT imaging is a cost-effective and simpler alternative to Gallium-68 PSMA PET-CT for diagnosing prostate cancer, including detecting primary tumors and metastases.

The study presents a case showing the use of 99mTc-PSMA imaging before therapy and 177Lu-PSMA imaging after therapy, highlighting the potential for effective monitoring of treatment response in prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tc-99m PSMA and Lu-177 PSMA Theranostic Pair in a Patient of Metastatic Castration Resistant Prostate Cancer. Sheikh, N., Younis, MN., Mumtaz, M., et al.[2022]

A systematic review of 16 studies involving 1309 patients found that 68Ga-PSMA PET scans are highly effective in detecting metastatic prostate cancer, with a 76% positivity rate in patients with biochemical recurrence, especially as pre-PET PSA levels increase.

The overall sensitivity and specificity of 68Ga-PSMA PET were found to be 86% and 80% respectively, indicating that this imaging technique is more reliable than traditional choline-based PET imaging for assessing prostate cancer spread.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity, Specificity, and Predictors of Positive 68Ga-Prostate-specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer: A Systematic Review and Meta-analysis. Perera, M., Papa, N., Christidis, D., et al.[2022]

68Ga-PSMA-11 PET imaging shows significantly higher sensitivity and specificity for diagnosing prostate cancer compared to conventional imaging methods, making it a valuable tool for initial staging and detecting recurrence.

In cases of biochemical recurrence, 68Ga-PSMA-11 PET/CT has higher detection rates than choline PET/CT, particularly in patients with low PSA levels, and it has led to changes in treatment plans for over 25% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Significance of PSMA imaging in prostate cancer]. Gasch, C., Düwel, C., Kopka, K., et al.[2022]

68Ga-PSMA PET/CT is highly effective for detecting recurrent prostate cancer, identifying cancer sites in 81% of patients with rising PSA levels after treatment, and showing a 50% detection rate for PSA levels between 0.2-0.49 ng/ml.

The imaging method demonstrated no reported adverse effects, making it a safe option for patients, and it outperformed traditional imaging methods like bone scans in detecting early recurrence of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-Labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Computed Tomography for Prostate Cancer: A Systematic Review and Meta-analysis. von Eyben, FE., Picchio, M., von Eyben, R., et al.[2022]

(68)Ga-PSMA PET/CT is a highly sensitive diagnostic tool for detecting primary prostate cancer and its metastases, outperforming traditional fluorine-18 choline PET/CT by identifying more metastases at lower PSA levels.

The (68)Ga-PSMA radioligand can be produced in hospitals using a gallium generator, making it a convenient and accessible option for prostate cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Not Available]. Lavalaye, J., Lam, MG., Verzijlbergen, JF., et al.[2021]

68Ga-PSMA-11 PET/CT has quickly become a valuable tool in prostate cancer imaging, showing high potential for primary diagnosis, staging, and monitoring biochemical recurrence based on numerous studies.

The review aims to summarize key data on 68Ga-PSMA-11 PET/CT and provide recommendations for its use in clinical practice, highlighting its effectiveness in improving patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 PET/CT: the rising star of nuclear medicine in prostate cancer imaging? Uprimny, C.[2021]

The introduction of (68)Gallium-labeled prostate-specific membrane antigen ((68)Ga-PSMA) in PET imaging shows promising results for diagnosing prostate cancer, offering a better lesion-to-background ratio due to its specific expression in prostatic tissue.

Combining (68)Ga-PSMA PET with MRI enhances the detection of prostate cancer by providing detailed morphological and functional information, potentially improving diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(68)Ga-PSMA PET/MR with multimodality image analysis for primary prostate cancer. Eiber, M., Nekolla, SG., Maurer, T., et al.[2021]

The imaging agent [68Ga]Ga-PSMA-093 shows excellent blood clearance and rapid tumor uptake, making it effective for detecting prostate cancer lesions, as confirmed by clinical studies.

Different sources of 68Ge/68Ga generators can be used to reliably produce [68Ga]Ga-PSMA-093 with high yields, ensuring the availability of this imaging tracer for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kit-based preparation of [68Ga]Ga-P16-093 (PSMA-093) using different commercial 68Ge/68Ga generators. Hong, H., Wang, G., Ploessl, K., et al.[2022]

The novel 68Ga-THP PSMA PET/CT imaging technique was found to be safe for use in prostate cancer patients, with no serious adverse events reported and only minor side effects observed in two patients.

This imaging method led to a change in clinical management for 42.9% of the patients evaluated, indicating its potential effectiveness in guiding treatment decisions for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II, Open-label study to assess safety and management change using 68Ga-THP PSMA PET/CT in patients with high risk primary prostate cancer or biochemical recurrence after radical treatment: The PRONOUNCED study. Afaq, A., Payne, H., Davda, R., et al.[2022]

In a study of 49 patients with intermediate and high-risk non-metastatic prostate cancer, 68Ga-PSMA PET/CT demonstrated a high specificity (96%) for detecting lymph node metastasis before radical prostatectomy, indicating its potential as a reliable diagnostic tool.

The sensitivity of 68Ga-PSMA PET/CT was lower at 60% in per-patient analysis but improved to 82% in per-node analysis, suggesting that while it is effective, there is still room for improvement in detecting all metastatic lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How accurate is 68Gallium-prostate specific membrane antigen positron emission tomography / computed tomography (68Ga-PSMA PET/CT) on primary lymph node staging before radical prostatectomy in intermediate and high risk prostate cancer? A study of patient- and lymph node- based analyses. Erdem, S., Simsek, DH., Degirmenci, E., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36900169/

Detection Efficacy of 68 Ga-PSMA-11 PET/CT in ... In biochemical recurrence of prostate cancer (BCR), prompt tumor localization guides early treatment, potentially improving patient outcomes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5871999/

Review of Gallium-68 PSMA PET/CT Imaging in the ... 68 Ga-PSMA PET/CT has the ability to reliably stage prostate cancer at presentation and can help inform an optimal treatment approach.

3. jnm.snmjournals.org jnm.snmjournals.org/content/63/2/240

Diagnostic Performance and Clinical Impact of 68 Ga-PSMA ... The PSMA PET/CT positivity rate was 65.1%, similar to the positivity rates reported in other studies, ranging overall from 63% to 75% (10,14,16, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03368547

Study Details | NCT03368547 | 68Ga-PSMA-11 PET/CT in ... This clinical trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with intermediate or ...

5. cancer.gov cancer.gov/research/participate/clinical-trials/intervention/gallium-ga-68-gozetotide?pn=1

Clinical Trials Using Gallium Ga 68 Gozetotide - NCI Review the clinical trials studying gallium ga 68 gozetotide on this list and use the filters to refine the results by age and location.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/212643s002lbl.pdf

GALLIUM GA 68 GOZETOTIDE Injection - accessdata.fda.gov The safety and effectiveness of Gallium Ga 68 Gozetotide Injection have not been established in pediatric patients. 8.5 Geriatric Use. The efficacy of Gallium ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/gallium-ga-68-psma-11-intravenous-route/description/drg-20506366

Gallium ga 68 psma-11 (intravenous route) - Side effects & ... Gallium Ga 68 PSMA-11 injection is used with a PET scan (positron emission tomography) of prostate-specific membrane antigen (PSMA) positive lesions in ...

8. illuccixhcp.com illuccixhcp.com/safety/

Safety Profile | Illuccix® (kit for the preparation of gallium Ga ... Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8401928/

[68Ga]Ga-PSMA-11: The First FDA-Approved 68Ga ... In numerous partly multicentric retrospective studies, [68Ga]Ga-PSMA-11 PET imaging has significantly improved the detection of recurrent prostate cancer as ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT02919111

Study Details | NCT02919111 | Gallium-68 PSMA-11 PET ... Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a ...