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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve prostate cancer diagnosis for men with a negative or unclear result from a previous prostate biopsy. It employs a special imaging agent, 68Ga-PSMA-11 (Gallium Ga 68 Gozetotide), which highlights prostate cancer cells on a PET/CT scan. By using these images to guide the biopsy, the trial aims to enhance cancer detection and avoid unnecessary treatment for low-risk cases while ensuring high-risk cases are identified. Men who require another biopsy and show signs of this imaging marker in their prostate may be suitable candidates for this trial. As an Early Phase 1 trial, this research focuses on understanding the imaging agent's function in people, offering participants a chance to contribute to pioneering advancements in prostate cancer diagnosis.

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 prior data suggests that this image-guided biopsy technique is safe for diagnosing prostate cancer?

Research shows that Gallium Ga 68 Gozetotide, used in this trial, is generally safe. The FDA has approved it for detecting prostate cancer, indicating it has been tested and found safe for people. In earlier studies, patients tolerated this imaging agent well. Some might experience mild side effects, such as headaches or nausea, but these are uncommon. Overall, existing research and its approved use consider the imaging agent safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PSMA-PET/CT guided biopsy for prostate cancer because it offers a more precise approach to diagnosing the disease. Unlike traditional biopsies that may randomly sample tissue, this method uses a special tracer, Gallium Ga 68 Gozetotide, to highlight cancerous areas within the prostate on a PET/CT scan. This targeted approach could lead to more accurate detection and better-informed treatment decisions, potentially improving outcomes for patients.

What evidence suggests that this image-guided biopsy is effective for diagnosing prostate cancer?

Research has shown that 68Ga-PSMA-11 PET/CT scans, which participants in this trial will undergo, are promising for detecting prostate cancer. Studies indicate that this imaging method successfully identifies cancer 65.1% of the time. It is particularly helpful for patients with low levels of prostate-specific antigen (PSA), as it can detect cancer when other tests might not. The 68Ga-PSMA-11 attaches to a protein on cancer cells, making tumors visible on scans. This precise detection can lead to better diagnosis and treatment decisions by accurately locating the cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Jeremie Calais

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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

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

I can stay still and lie flat for 30 minutes.

Inability to provide written informed consent

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

(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]

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)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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39162634/

Quantitative 68Ga-PSMA-11 PET and Clinical Outcomes in ... Baseline 68 Ga-PSMA-11 PET/CT whole-body tumor SUV mean was the best predictor of 177 Lu-PSMA-617 efficacy in participants in the VISION trial.

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

Detection Efficacy of 68 Ga-PSMA-11 PET/CT in ... Our observations suggest the potential value of 68 Ga-PSMA-11 PET/CT in the very low PSA BCR setting, especially in cases with more rapid PSA doubling time or ...

3. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.233460

Quantitative 68 Ga-PSMA-11 PET and Clinical Outcomes ... Higher PSMA-positive tumor volume was associated with worse overall survival (HR range, 1.38–2.12; P ≤ .006). Introduction. Prostate-specific ...

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

Diagnostic Performance and Clinical ... 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, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03396874

Study Details | NCT03396874 | Gallium-68 PSMA-11 PET ... This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, ...

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

GALLIUM GA 68 GOZETOTIDE Injection - accessdata.fda.gov The safety and efficacy of Gallium Ga 68 Gozetotide Injection were established in two prospective, open- label studies, PSMA-PreRP (NCT03368547 and NCT02919111 ...

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 ... [68Ga]Ga-PSMA-11 is a diagnostic radiotracer for the localization of PSMA-positive lesions in men with prostate cancer using PET [48]. It is indicated in cases ...

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 ...