PSMA-PET/CT Guided Biopsy for Prostate Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Jonsson Comprehensive Cancer Center
Disqualifiers: Negative PSMA uptake, Recurrent cancer, others
No Placebo Group
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.12345
Is the PSMA-PET/CT Guided Biopsy for Prostate Cancer safe for humans?
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.235910
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.
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Trial 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 (Procedure)
- Gallium Ga 68 Gozetotide (Imaging Agent)
- Transrectal Ultrasonography Guided Biopsy (Procedure)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)Experimental Treatment3 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
References
Safety and Diagnostic Yield of 68Ga Prostate-specific Membrane Antigen PET/CT-guided Robotic-assisted Transgluteal Prostatic Biopsy. [2022]Background Transrectal US-guided biopsy with or without MRI fusion is performed for diagnosing prostate cancer (PCa) but has limitations. Gallium 68 (68Ga) prostate-specific membrane antigen (PSMA) PET/CT-guided targeted biopsy has the potential to improve diagnostic yield of PCa. Purpose To evaluate the safety and diagnostic yield of 68Ga PSMA PET/CT-guided, robotic-arm assisted transgluteal prostatic biopsy. Materials and Methods In this single-center nonrandomized prospective trial, participants with a clinical suspicion of PCa (serum prostate-specific antigen level > 4 ng/mL) were recruited from January 2019 to September 2020. After whole-body 68Ga PSMA PET/CT, participants with PSMA-avid intraprostatic lesions underwent PET-guided transgluteal biopsy by using an automated robotic arm. To assess safety and diagnostic yield, procedure-related complications and histopathologic results were documented. Pain during the procedure was scored by a visual analog scale. Descriptive statistics were applied; qualitative variables were reported in percentages. Results Seventy-eight participants (mean age, 66 years ± 7 [standard deviation]; 36 participants [46%] with prior negative results at transrectal US-guided biopsy) were enrolled. Fifty-six (72%) participants had PSMA-avid lesions (prior negative results at transrectal US-guided biopsy in 22 of 56 [39%]) and underwent targeted biopsy. PCa was confirmed in 54 of 56 (96%) participants, and clinically significant PCa (Gleason score ≥ 7) was confirmed in 24 of 54 (44%). Two participants had nonrepresentative samples that required rebiopsy. All participants experienced pain during the procedure, mild (median visual analog scale score, 1; interquartile range, 1-2) in 36 of 56 (64%) and moderate (median visual analog scale score, 5; interquartile range, 5-6) in 20 of 56 (36%). Postprocedure complications were noted in five of 56 (9%) participants and were minor (hematuria, four participants; hematospermia, one participant; and gluteal pain, two participants). No participant developed a postprocedural infection. Conclusion Transgluteal prostate-specific membrane antigen (PSMA) PET/CT-guided, robotic-targeted prostatic biopsy is safe with a high diagnostic yield of prostate cancer for PSMA-avid lesions. Clinical trial registration no. NCT05022576 © RSNA, 2022.
Delayed 68Ga-PSMA PET/CT Image-Guided Biopsy for Low-Grade Adenocarcinoma in Benign Prostatic Hyperplasia. [2023]Image-guided biopsy of prostate with multiparametric MRI is being adopted in the workup of prostate adenocarcinoma (PAC). 68Ga-PSMA PET/CT-guided biopsy has also been shown to be equally sensitive in the evaluation of higher-grade tumors with increased PSMA expression. The sensitivity of 68Ga-PSMA PET/CT, however, reduces with lesser PSMA expression in low-grade PAC. Herein, we demonstrate a case where delayed 68Ga-PSMA PET/CT imaging helped in detecting low-grade PAC in BPH.
[Not Available]. [2021](68)Gallium (Ga)-PSMA PET/CT (PSMA stands for "prostate-specific membrane antigen") is a new diagnostic tool for patients with prostate cancer or with prostate cancer metastases. PET/CT is a combination scan which uses the physiological information of the PET scan and the anatomic information of the CT scan. The radioligand (68)Ga-PSMA is a radioactively labelled peptide that binds to the membrane protein PSMA. Prostate cancer cells in the primary tumour and in metastases express increased levels of PSMA in the plasma membrane. A number of studies have shown that (68)Ga-PSMA PET/CT is sensitive in detecting primary prostate cancer and metastases in lymph nodes and bone. In the same patient, (68)Ga-PSMA PET/CT detects more metastases in an earlier phase, i.e. at a lower PSA level, than fluorine-18 choline PET/CT. Furthermore, the (68)Ga-PSMA can be produced in the investigating hospital with a gallium generator. The expectation is that the use of (68)Ga-PSMA PET/CT will increase to a major extent over the coming years in patients with prostate cancer.
[Diagnostic performance of 68GA-PSMA PET/CTin patients with prostate cancer]. [2019]and aim. Most of the patients with biochemical recurrence after radical prostatectomy undergo salvage radiotherapy without guidance from imaging. In recent years, there has been an increasing role of Gallium-68 prostate specific membrane antigen (68Ga-PSMA) positron emission tomography/computed tomography (PET/CT) imaging in the management of prostate cancer. This study aimed to investigate diagnostic performance of 68Ga-PSMA PET/CT in patients with biochemical recurrence after radical prostatectomy.
[Introduction of PSMA PET requires thorough research]. [2019](68)Gallium (Ga)-PSMA PET/CT scans have been introduced in clinical practice in the Netherlands too. Although there are some indications that this new imaging modality for prostate cancer might be superior to other techniques, evidence is lacking both for primary diagnosis and in the case of recurrent disease. The exact role of the (68)Ga-PSMA PET/CT scan needs to be defined on the basis of well-designed studies that also evaluate the impact of earlier diagnosis on the outcome for the individual patient.
Kit-based preparation of [68Ga]Ga-P16-093 (PSMA-093) using different commercial 68Ge/68Ga generators. [2022]Label="PURPOSE">Prostate-specific membrane antigen (PSMA) is an important biomarker for molecular imaging and a target for radionuclide therapy of prostate cancer. Recently, U.S. Food and Drug Administration (FDA) has approved [68Ga]Ga-PSMA-11 as a PSMA-targeted positron emission tomography (PET) imaging agent for the diagnosis of prostate cancer. As an alternative PSMA imaging agent, [68Ga]Ga-P16-093 ([68Ga]Ga-PSMA-093) showed excellent blood clearance and rapid tumor uptake, desirable in vivo properties for avidly detecting primary tumor and metastatic lesions in patients. To improve the availability and test the robustness of radiolabeling reaction, eluents of 68Ga/HCl from different sources of generators were evaluated.
Preclinical Evaluation of a Fibroblast Activation Protein and a Prostate-Specific Membrane Antigen Dual-Targeted Probe for Noninvasive Prostate Cancer Imaging. [2023]Prostate-specific membrane antigen (PSMA) is a prostate cancer target that plays a crucial role in prostate cancer diagnosis and therapy. Herein, a novel dual-targeted imaging probe, [68Ga]Ga-FAPI-PSMA, was prepared by radiolabeling conjugated DOTA-FAPI-PSMA with the short half-life radionuclide gallium-68 (68Ga), which is dedicated to prostate cancer diagnostic imaging. In vitro, [68Ga]Ga-FAPI-PSMA had higher affinity for the PSMA and FAP high-expressing cell lines 22Rv1 and U87 MG with IC50 values of 4.73 and 2.10 nM, respectively, than in the corresponding negative expression cell lines PC3 and A549, and significant differences in cell uptake were also observed. In vivo, [68Ga]Ga-FAPI-PSMA was rapidly cleared from the body, and the estimated radiation dose was relatively low compared with several other FAPI probes. In 22Rv1 and U87 MG tumor xenografts, [68Ga]Ga-FAPI-PSMA rapidly accumulated in tumors after administration, and the best images can be obtained at 1 h postinjection. In conclusion, the dual-targeted probe [68Ga]Ga-FAPI-PSMA was successfully prepared for in vivo prostate cancer PET/CT imaging.
Normal distribution pattern and physiological variants of 68Ga-PSMA-11 PET/CT imaging. [2022]Ga-PSMA-11 is a novel PET tracer suggested to be used for imaging of advanced prostate cancer. In this study, we aimed to present a detailed biodistribution of Ga-PSMA-11, including physiological and benign variants of prostate-specific membrane antigen (PSMA) imaging.
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]Label="PURPOSE"> 68Ga-prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) is valuable for detecting primary and recurrent prostatic lesions. This study aimed to evaluate the efficacy of 68Ga-PSMA-11 PET/CT as a triage tool for prostate biopsy (PSMA-TB) and compare with transrectal ultrasound-guided biopsy (TRUS-GB) for the diagnosis of clinically significant prostate cancer (csPCa).
Specificity of 68Ga-PSMA PET/CT for Prostate Cancer - Myths and Reality. [2020]68Ga-PSMA ligand PET/CT for imaging prostate cancer is a novel imaging technique, which is rapidly gaining popularity. Sufficient evidence has been accumulated in literature regarding the usefulness of 68Ga-PSMA PET/CT in prostate cancer. Recently literature regarding the localization of 68Ga-PSMA PET/CT imaging in non-prostatic malignancies is also published, thus questioning the specificity of the tracer with regards to prostate cancer. This commentary tries to address the issue of specificity of 68Ga-PSMA PET/CT and its relevance in imaging prostate cancer.