PSMA-PET CT Imaging for Prostate Cancer (ESCAPE Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Overseen ByTimothy Mcclure, M.D.
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Weill Medical College of Cornell University
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This study will be assessing the ability of PSMA-PET CT to determine the absence of clinically significant prostate cancer in patients on active surveillance (AS) with low risk and favorable intermediate-risk prostate cancer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment PSMA-PET CT Imaging for Prostate Cancer?
Research shows that 68Ga-PSMA PET/CT is effective in detecting prostate cancer relapses and metastases, helping in accurate staging and planning of radiation therapy. It is also useful in identifying primary prostate cancer, potentially reducing the need for unnecessary biopsies.
12345Is PSMA-PET CT Imaging safe for humans?
Research shows that PSMA-PET CT Imaging, specifically using 68Ga-THP PSMA, is generally safe for humans. In a study with 49 patients, no serious adverse events were reported, and only two patients experienced mild side effects like itching and a rash at the injection site.
46789How is PSMA-PET CT imaging different from other treatments for prostate cancer?
PSMA-PET CT imaging is unique because it uses a special imaging technique that targets the prostate-specific membrane antigen (PSMA) to provide highly detailed pictures of prostate cancer, helping in accurate diagnosis, staging, and treatment planning. This method is more precise than traditional imaging techniques, potentially reducing the need for invasive procedures like biopsies.
234710Eligibility Criteria
Men over 18 with low or favorable intermediate-risk prostate cancer, as defined by NCCN guidelines, can join. They must have a PSA level under 20 ng/ml and be able to undergo yearly PSMA-PET CT scans, prostate biopsies, and mpMRI. Those not interested in active surveillance or with prior treatments for prostate cancer cannot participate.Participant Groups
The trial is testing the effectiveness of PSMA-PET CT scans in monitoring patients with low to intermediate-risk prostate cancer who are on active surveillance. The goal is to see if this imaging technique can reliably detect the absence of significant cancer progression.
1Treatment groups
Experimental Treatment
Group I: PSMA-PET CTExperimental Treatment1 Intervention
Patients will undergo PSMA-PET CT (Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography) at baseline, 12 month and 24 month time point.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
UCSFSan Francisco, CA
UCLALos Angeles, CA
Weill Cornell Medicine - New York Presbyterian HospitalNew York, NY
Case Western University HospitalsCleveland, OH
More Trial Locations
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
References
68Ga-PSMA PET/CT in Patients with Rising Prostatic-Specific Antigen After Definitive Treatment of Prostate Cancer: Detection Efficacy and Diagnostic accuracy. [2021]Label="RATIONALE AND OBJECTIVES"> 68Ga-prostate-specific membrane antigen-11 (68Ga-PSMA-11) is a recently developed positron emission tomography (PET) tracer that can detect prostate cancer (PC) relapses and metastases with high contrast resolution. The aim of this study was to assess the detection efficacy and diagnostic accuracy of 68Ga-PSMA PET/CT image in patients with rising prostatic-specific antigen (PSA) after treatment of PC.
The influence of 68Ga-prostate-specific membrane antigen PET/computed tomography on prostate cancer staging and planning of definitive radiation therapy. [2023]Prostate-specific membrane antigen (PSMA) PET/computed tomography (CT) is a novel imaging tool with an evolving role in the management of prostate cancer. This study aims to retrospectively evaluate the impact of 68Ga-PSMA PET/CT on prostate cancer staging and definitive radiation therapy planning.
Tc-99m PSMA and Lu-177 PSMA Theranostic Pair in a Patient of Metastatic Castration Resistant Prostate Cancer. [2022]Prostate specific membrane antigen (PSMA) targeted PET-CT imaging labeled with Gallium-68 (68Ga) is a standard diagnostic investigation in patients of carcinoma of prostate, for detection of primary tumour, initial staging of high risk disease for metastases as well as detection of recurrence. 99mTechnetium labeled PSMA SPECT-CT is a more cost-effective and logistically simple alternative for it. We present pre-therapy images of 99mTc-PSMA and post-therapy scan with 177Lu- PSMA in the same patient.
Role of 68Ga-PSMA-PET/CT for the detection of primary prostate cancer prior to biopsy: a prospective study. [2022]Prostate-specific membrane antigen (PSMA) positron emission tomography/ computed tomography (PET-CT) is widely used as a staging tool for patients with prostate cancer (PCa). The objective of the study is to assess the diagnostic accuracy of 68Ga-PSMA-PET/CT for PCa, which may help us avoid unnecessary biopsies in patients with intermediate prostate-specific antigen (PSA) levels.
A Prospective Study on [68Ga]-PSMA PET/CT Imaging in Newly Diagnosed Intermediate- and High-Risk Prostate Cancer. [2022]Label="OBJECTIVES" NlmCategory="OBJECTIVE">Prostate-specific membrane antigen (PSMA) ligand positron emission tomography/computed tomography (PET/CT) is an emerging modality to detect metastatic disease in patients with prostate cancer (PCa). This prospective study aimed to evaluate the role of [68Ga]-PSMA PET/CT in the initial workup of intermediate and high-risk PCa.
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. [2022]Objectives: To assess the safety and clinical impact of a novel, kit-based formulation of 68Ga-THP PSMA positron emission tomography/computed tomography (PET/CT) when used to guide the management of patients with prostate cancer (PCa). Methods: Patients were prospectively recruited in to one of: Group A: high-risk untreated prostate cancer; Gleason score >4+3, or PSA >20 ng/mL or clinical stage >T2c. Group B: biochemical recurrence (BCR) and eligible for salvage treatment after radical prostatectomy with two consecutive rises in prostate specific antigen (PSA) with a three month interval in between reads and final PSA >0.1 ng/mL or a PSA level >0.5 ng/mL. Group C: BCR with radical curative radiotherapy or brachytherapy at least three months prior to enrolment, and an increase in PSA level >2.0 ng/mL above the nadir level after radiotherapy or brachytherapy. Patients underwent evaluation with PET/CT 60 minutes following intravenous administration of 160±30 MBq of 68Ga-THP PSMA. Safety was assessed by means including vital signs, cardiovascular profile, serum haematology, biochemistry, urinalysis, PSA, and Adverse Events (AEs). A change in management was reported when the predefined clinical management of the patient altered as a result of 68Ga-THP PSMA PET/CT findings. Results: Forty-nine patients were evaluated with PET/CT; 20 in Group A, 21 in Group B and 8 in Group C. No patients experienced serious AEs discontinued the study due to AEs, or died during the study. Two patients had Treatment Emergent AEs attributed to 68Ga-THP-PSMA (pruritus in one patient and intravenous catheter site rash in another). Management change secondary to PET/CT occurred in 42.9% of all patients; 30% in Group A, 42.9% in Group B and 75% in Group C. Conclusion: 68Ga-THP PSMA was safe to use with no serious AE and no AE resulting in withdrawal from the study. 68Ga-THP PSMA PET/CT changed the management of patients in 42.9% of the study population, comparable to studies using other PSMA tracers. These data form the basis of a planned Phase III study of 68Ga-THP PSMA in patients with prostate cancer.
68Ga-PSMA-11 PET/CT: the rising star of nuclear medicine in prostate cancer imaging? [2021]Ever since the introduction of 68Ga-prostate-specific membrane antigen 11 positron-emission tomography/computed tomography (68Ga-PSMA-11 PET/CT) a few years ago, it has rapidly achieved great success in the field of prostate cancer imaging. A large number of studies have been published to date, indicating a high potential of 68Ga-PSMA-11 PET/CT in the work-up of prostate cancer patients, including primary diagnosis, staging and biochemical recurrence. The aim of this review is to present the most important data on this novel, highly promising imaging technique, and to formulate recommendations for possible applications of 68Ga-PSMA-11 PET/CT in clinical routine.
[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.
[68Ga]Ga-PSMA-11 in prostate cancer: a comprehensive review. [2020]Imaging of the prostate-specific membrane antigen (PSMA) has become an important tool for managing patients with recurrent prostate cancer, and one of the most frequently employed radiopharmaceuticals is [68Ga]Ga-PSMA-11. Herein, we summarize the preclinical development and the clinical applications of [68Ga]Ga-PSMA-11 and present side-by-side comparisons with other radiopharmaceuticals or imaging modalities, in order to assist imagers and clinicians in recommending, performing, and interpreting the results of [68Ga]Ga-PSMA-11 PET scans in patients with prostate cancer.
Lymph node staging with 68Ga-PSMA PET in patients with intermediate and high-risk prostate cancer suitable for radical prostatectomy managed in a prostate cancer unit. [2023]Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) is coming up as a superior imaging tool for prostate cancer (PCa). However, its use in primary staging is still debated. The aim of this study was to assess accuracy of 68Ga-PSMA PET/CT in staging patients with intermediate and high risk PCa candidates to radical prostatectomy managed in the Prostate Cancer Unit of our institution.