PSMA-PET/CT Guided Biopsy for Prostate Cancer

Overseen By Wesley Armstrong

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Negative PSMA uptake, Recurrent cancer, others

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

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This early phase I trial studies how well an image-guided prostate biopsy using the imaging agent 68Ga-prostate-specific membrane antigen (PSMA)-11 with a positron emission tomography/computed tomography (PET/CT) scan works in diagnosing prostate cancer in men with a prior negative or inconclusive prostate biopsy. PSMA is a protein that is found on the surface of prostate cancer cells. 68Ga-PSMA-11 is made up of a substance that binds to PSMA on tumor cells, linked with a radioactive substance that can then be seen on imaging scans such as PET/CT. 68Ga-PSMA-11 PET/CT-guided biopsy may help improve the detection rate of prostate cancer. This may help reduce over-diagnosis and over-treatment in men with low-risk prostate cancer and under-treatment in men with high-risk prostate cancer.

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

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What data supports the effectiveness of the treatment PSMA-PET/CT Guided Biopsy for Prostate Cancer?

Research shows that 68Ga-PSMA PET/CT-guided biopsy is effective in diagnosing prostate cancer, with a high success rate of confirming cancer in patients with PSMA-avid lesions. It is also noted for its safety and ability to detect more metastases at an earlier stage compared to other imaging techniques. ^{1 2 3 4 5}

Is the PSMA-PET/CT Guided Biopsy for Prostate Cancer safe for humans?

The PSMA-PET/CT guided biopsy for prostate cancer is generally safe, with minor complications like blood in urine or semen and mild to moderate pain reported in some participants. No serious infections were observed in the study. ^{1 3 6 7 8}

How is the PSMA-PET/CT Guided Biopsy treatment for prostate cancer different from other treatments?

The PSMA-PET/CT Guided Biopsy treatment is unique because it uses a special imaging technique that combines PET and CT scans with a radioactive tracer, Gallium Ga 68 Gozetotide, to detect prostate cancer cells more accurately and at an earlier stage than traditional methods. This approach allows for more precise targeting during biopsies, potentially improving the diagnosis of significant prostate cancer. ^{2 3 5 9 10}

Research Team

Jeremie Calais

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for men who are suspected to have clinically significant prostate cancer but had previous inconclusive or negative biopsies. They must show focal uptake of a tracer in the prostate and be scheduled for another biopsy. Men under 18, over 90, or unable to lie still for PET/CT scans cannot participate.

Inclusion Criteria

I am a man who might have serious prostate cancer, but my previous prostate biopsy was unclear or negative.

I am scheduled for a repeat prostate biopsy.

My prostate cancer shows up on a specific PET scan.

Exclusion Criteria

I am younger than 18 or older than 90.

Negative 68Ga-PSMA-11 uptake within the prostate (screening failure)

I can stay still and lie flat for 30 minutes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Image-Guided Biopsy

Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care TRUS.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the biopsy procedure

Up to 3 years

Treatment Details

Interventions

• Biopsy of Prostate
• Gallium Ga 68 Gozetotide
• Transrectal Ultrasonography Guided Biopsy

Trial Overview The study tests if using a radioactive imaging agent called 68Ga-PSMA-11 with PET/CT scans can better diagnose prostate cancer during biopsies after earlier tests failed to confirm the disease.

Participant Groups

Group I: Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy) Experimental Treatment 3 Interventions

SCREENING PROCEDURE: Patients receive 68Ga-PSMA-11 IV and 50-100 minutes later, undergo a PET/CT scan. Only patients with 68Ga-PSMA-11 uptake within the prostate proceed to image-guided biopsy. IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care TRUS.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Findings from Research

The study involved 78 participants suspected of having prostate cancer, and the use of 68Ga PSMA PET/CT-guided robotic-arm assisted biopsy resulted in a high diagnostic yield, confirming prostate cancer in 96% of those with PSMA-avid lesions.

The procedure was found to be safe, with only minor complications reported in 9% of participants and no infections, while pain levels during the biopsy were generally mild to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Diagnostic Yield of 68Ga Prostate-specific Membrane Antigen PET/CT-guided Robotic-assisted Transgluteal Prostatic Biopsy. Kumar, R., Singh, SK., Mittal, BR., et al.[2022]

Image-guided biopsy using multiparametric MRI is becoming a standard method for diagnosing prostate adenocarcinoma (PAC), showing effectiveness in identifying tumors.

The use of delayed 68Ga-PSMA PET/CT imaging can enhance the detection of low-grade PAC, particularly in cases where traditional imaging may miss tumors due to lower PSMA expression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed 68Ga-PSMA PET/CT Image-Guided Biopsy for Low-Grade Adenocarcinoma in Benign Prostatic Hyperplasia. Santhosh, S., Jeeva, G.[2023]

(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]

In a study of 19 prostate cancer patients, 68Ga-PSMA PET/CT imaging successfully identified recurrence in 15 out of 17 patients with biochemical recurrence after radical prostatectomy, demonstrating its effectiveness in early detection of cancer spread.

The imaging technique revealed positive sites of recurrence in both single and multiple locations, leading to salvage lymphadenectomy in four patients, with histological confirmation of malignancy in three cases, highlighting its potential to guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic performance of 68GA-PSMA PET/CTin patients with prostate cancer]. Veliev, EI., Tomilov, AA., Goncharuk, DA., et al.[2019]

(68)Gallium (Ga)-PSMA PET/CT scans are now being used in clinical practice in the Netherlands for prostate cancer, showing potential advantages over traditional imaging methods.

However, there is currently insufficient evidence to fully establish the effectiveness of Ga-PSMA PET/CT scans for both initial diagnosis and recurrent disease, highlighting the need for further well-designed studies to clarify their role and impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Introduction of PSMA PET requires thorough research]. de Reijke, TM., van Moorselaar, JR.[2019]

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 imaging probe [68Ga]Ga-FAPI-PSMA shows high affinity for prostate cancer cells, making it effective for diagnostic imaging, with IC50 values of 4.73 nM for PSMA and 2.10 nM for FAP expressing cells.

In vivo studies demonstrated that [68Ga]Ga-FAPI-PSMA rapidly accumulates in prostate tumors and provides optimal imaging results at 1 hour post-injection, while also having a relatively low radiation dose compared to other imaging probes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Evaluation of a Fibroblast Activation Protein and a Prostate-Specific Membrane Antigen Dual-Targeted Probe for Noninvasive Prostate Cancer Imaging. Wang, P., Wang, S., Liu, F., et al.[2023]

Ga-PSMA-11 is a promising PET tracer for imaging advanced prostate cancer, showing specific uptake patterns in various organs, which helps in understanding its biodistribution and potential physiological variants.

The study identified normal uptake in the prostate and other organs, as well as benign lesions, which is crucial for avoiding misinterpretations during scans and ensuring accurate diagnosis in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Normal distribution pattern and physiological variants of 68Ga-PSMA-11 PET/CT imaging. Demirci, E., Sahin, OE., Ocak, M., et al.[2022]

The study involving 120 patients showed that 68Ga-PSMA-11 PET/CT significantly improved the detection rates of clinically significant prostate cancer (csPCa) compared to traditional transrectal ultrasound-guided biopsy (TRUS-GB), especially in patients with PSA levels between 4.0-20.0 ng/ml.

PSMA-targeted biopsy (PSMA-TB) was found to be safer than TRUS-GB, with no reported cases of complications such as haematuria, urinary retention, or pelvic infection, highlighting its potential as a preferred method for prostate cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA PET/CT targeted biopsy for the diagnosis of clinically significant prostate cancer compared with transrectal ultrasound guided biopsy: a prospective randomized single-centre study. Zhang, LL., Li, WC., Xu, Z., et al.[2021]

68Ga-PSMA ligand PET/CT is an emerging imaging technique that has shown significant promise in effectively imaging prostate cancer, as supported by accumulating evidence in the literature.

Recent studies have raised questions about the specificity of 68Ga-PSMA PET/CT for prostate cancer, as it has also been observed to localize in non-prostatic malignancies, which could impact its diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specificity of 68Ga-PSMA PET/CT for Prostate Cancer - Myths and Reality. Sasikumar, A.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and Diagnostic Yield of 68Ga Prostate-specific Membrane Antigen PET/CT-guided Robotic-assisted Transgluteal Prostatic Biopsy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Delayed 68Ga-PSMA PET/CT Image-Guided Biopsy for Low-Grade Adenocarcinoma in Benign Prostatic Hyperplasia. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Not Available]. [2021]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Diagnostic performance of 68GA-PSMA PET/CTin patients with prostate cancer]. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[Introduction of PSMA PET requires thorough research]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Kit-based preparation of [68Ga]Ga-P16-093 (PSMA-093) using different commercial 68Ge/68Ga generators. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Preclinical Evaluation of a Fibroblast Activation Protein and a Prostate-Specific Membrane Antigen Dual-Targeted Probe for Noninvasive Prostate Cancer Imaging. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Normal distribution pattern and physiological variants of 68Ga-PSMA-11 PET/CT imaging. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

68Ga-PSMA PET/CT targeted biopsy for the diagnosis of clinically significant prostate cancer compared with transrectal ultrasound guided biopsy: a prospective randomized single-centre study. [2021]

10. India pubmed.ncbi.nlm.nih.gov

Specificity of 68Ga-PSMA PET/CT for Prostate Cancer - Myths and Reality. [2020]