Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Endodermal Sinus Tumor

Teratoma

Testicular Neoplasms

Retroperitoneal Neoplasms

Testicular Diseases

Choriocarcinoma

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Endocrine System Diseases

Gonadal Disorders

Trophoblastic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Pregnancy Complications

Pregnancy Complications, Neoplastic

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Abdominal Neoplasms

Germ Cells Tumors

Testicular Germ Cell Tumor

Testicular Yolk Sac Tumor

Only one arm is being evaluated--the arm receiving PET scan

Axumin PET scan

Yair Lotan, MD

Investigators will use Axumin PET/CT to help with the imaging modalities to determine the presence of occult retroperitoneal disease.

Investigators aim to perform a prospective study of anti-18F-FACBC PET/CT in patients with NSGCT prior to RPLND, either in the primary setting or in the post-chemotherapy setting. We will correlate histopathologic outcomes from the RPLND specimen and clinical outcomes of recurrence during follow-up to identify the accuracy of anti-18F-FACBC PET/CT in these settings.

Males with germ cell tumors (testicular cancer)

Role of Axumin PET Scan in Germ Cell Tumor

Anti-1-amino-3-18F-flurocyclobutane-1-carboxylic Acid (Axumin) Positron Emission Tomography/Computed Tomography Prior to Retroperitoneal Lymph Node Dissection for Testicular Cancer

Investigate the accuracy of anti-18F-FACBC PET/CT correlating with histopathologic outcomes

University of Texas Southwestern Medical Center

Professor of Urology

Symptoms and General Pathology

Recurrence

Prostatic Neoplasms

Prostatic Diseases

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Androgens

Hormones

Leuprolide

Bicalutamide

Androgen Antagonists

Hormone Antagonists

Post-radical prostatectomy patients fitting our inclusion criteria, including rising PSA \> 0.1 ng/ml, a positive SOC Axumin scan, and a patients not having received hormonal therapy for a minimum of 3 months, will receive hormonal therapy in the form of Casodex for 2 weeks, followed by Lupron indefinitely. Patients will then receive serial Axumin scans up to 1 year post-therapy.

Post-radical prostatectomy patients fitting our inclusion criteria, including rising PSA \> 0.1 ng/ml, not concurrently on androgen deprivation therapy (ADT) and/or received ADT in the past 3 months, and a positive SOC Axumin scan, will receive salvage radiation therapy according to the following protocol. External beam radiation therapy will be delivered in the form of high-dose intensity modulated radiation therapy (IMRT). A total prescribed dose of 72 Gy will be delivered in 40 fractions over 8 weeks. For the first 25 fractions, the clinical target volume (CTV) is defined as the residual prostatic bed, plus internal/external iliac nodes. For the subsequent 15 fractions the CTV is defined as the residual prostatic bed plus margin. As part of SOC, the radiation fields will incorporate the Axumin positive areas into treatment planning objectives. Patients will then receive serial Axumin scans up to 1 year post-therapy.

Patients will receive hormone therapy if Axumin positive area appears.

Casodex, Axumin

Patients will receive salvage radiation therapy if Axumin positive area appears.

Salvage Radiation, Axumin

Kenneth M Tokita, MD

This project seeks to use advanced imaging (specifically, positron emission tomography/computed tomography \[PET/CT\]) to detect, locate, and characterize recurrent disease in the setting of patients with prostate cancer.

This protocol details the study design for patients with prostate cancer (PCa) who have failed primary treatment with radical prostatectomy, and now have rising PSA as indicated by a recent PSA blood draw value \> 0.1 ng/ml. Patients fitting our inclusion criteria for the study, will receive an Axumin scan as part of their standard of care (SOC) treatment. If the SOC scan is positive, patients under this protocol will either subsequently receive hormone therapy OR salvage radiation therapy (not both concurrently). Patient response to therapy will be assessed with serial Axumin scans identifying additional lesions present at 3 months, 6 months, and 12 months (1 year) post-therapy, with the latter time point being our endpoint of the study.

The study aims are as follows:

1. The investigators would like to understand the hormonal therapy response based on Axumin scans administered over a time course of 3 months, 6 months, and 12 months post-hormone therapy treatment.
2. The investigators would like to understand the salvage radiotherapy response based on Axumin scan results incorporated into radiation treatment planning over a time course of 3 months, 6 months, and 12 months post-salvage radiation treatment.

Defining Recurrent Disease With Axumin™

Diagnosing and Monitoring Recurrent Disease in Prostate Cancer Patients Using a Positron Emission Tomography Radiotracer (Axumin™)

Utilizing standard uptake values (SUV) from the tumor origin, serial Axumin SUV values will be calculated as a percentage of the baseline SUV value.

Prostate specific antigen (PSA) values expressed as \[ng/ml\] will be serially drawn at each time of the Axumin scan to correlate with percentage of baseline SUV value.

Cancer Center of Irvine

Neoplastic Cells, Circulating

Neoplasm Metastasis

Neoplastic Processes

Patients with low or very low risk prostate cancer who have been on active surveillance for 5 or more years with a stable PSA or on active surveillance for 2 or more years with negative multiparametric MRI (mpMRI) or mpMRI with a fusion biopsy(ies) confirming low risk disease.

Men with high-risk localized prostate cancer, defined as stage pT3a or Gleason score greater than or equal to 8 and/or pre-prostatectomy PSA of greater than or equal to 20 ng/mL.

Systemic and/or hormonal treatment naive men with localized prostate cancer (pathological stages pT2, pT3a or pT4 with TNM N0 or N1 and M0 disease) who have clinical suspicion of biochemical recurrence 2 - 5 months following radical prostatectomy and are scheduled to undergo NGI (i.e., Axumin® or PSMA PETCT) within the next 45 days or have already undergone NGI within the past 45 days.

Patients with evidence of non-metastatic castration-resistant prostate cancer (i.e. localized prostate cancer patients with clinical symptoms of disease progression and/or evidence of a rising PSA following hormone therapy) who are scheduled to undergo NGI (i.e., Axumin® or PSMA PETCT) within the next 45 days or have already undergone NGI within the past 45 days and who have not started a new therapy for treatment of their castration-resistant prostate cancer.

Peripheral blood will be collected from each subject at a single time point and data will be collected from a review of each subject's medical records.

Blood collection

Jose G Moreno, MD

This study is designed to evaluate the presence and numbers of circulating tumor cells (CTCs) and cancer related gene expression levels in subjects with localized high-risk prostate cancer (HRLPC) and from subjects with non-metastatic disease experiencing biochemical recurrence and castration-resistance (BCRLPC and NMCRPC groups, respectively) who are about to undergo next generation imaging (NGI, such as Axumin® or PSMA PETCT). The investigators will also evaluate subjects with localized indolent prostate cancer who are on active surveillance (AS) as a control population. The CTC and gene expression results will be evaluated for association with disease state and progression and survival.

Patients who meet the eligibility criteria and provide written informed consent will be enrolled into the study. The four (4) groups of patients to be enrolled into the study will consist of: 1) men with low risk localized prostate cancer (LPC) on active surveillance (AS control group), 2) treatment naïve men with high risk LPC (HRLPC) who are 2 - 5 months out after having a radical prostatectomy, 3) treatment naïve men with biochemically recurrent LPC (BCRLPC) who are about to or have recently undergone next generation imaging \[NGI\] (i.e. Axumin® or PSMA PETCT), and men with non-metastatic castration resistant prostate cancer (NMCRPC) who are about to or have recently undergone NGI (i.e. Axumin® or PSMA PETCT). The goal is to enroll a total of 25 evaluable patients into each study group (HRLPC, BCRLPC, NMCRPC and AS) and collect up to \~29mL of blood from each patient as a single timepoint for evaluation. HRLPC patients will have blood draw 2 - 5 months following their radical prostatectomy procedure, BCRLPC and NMCRPC patients will have their blood drawn within 45 days prior to or after their scheduled NGI study and prior to initiation of a new treatment for their disease, and AS patients will have their blood drawn either after having a stable PSA for greater than 5 years or greater than 2 years after having a biopsy confirming low risk disease. All patients will be followed for up to 2 years after enrollment for disease progression and survival status.

Whole blood samples will be collected, and the following will be isolated from the whole blood samples: serum, plasma, cells (e.g., CTCs, white blood cells, etc.), circulating cell free DNA, DNA and RNA from isolated cells, etc.

Characterization of Circulating Tumor Cells (CTCs) in High Risk and Early Metastatic Prostate Cancer Patients Using Parsortix® System

ANG-015 / MLU-3 (CHARTER Study): Characterization of Circulating Tumor Cells Isolated Using the Parsortix® System in High Risk and Early Metastatic Prostate Cancer Patients

Data from this study will not be shared with other researchers.

The population of cells captured from the peripheral blood samples by the Parsortix system will be evaluated using cytological and/or immunofluorescent staining methods to determine the numbers and phenotypes of any rare cells present (e.g., epithelial and/or mesenchymal CTCs, megakaryocytes, etc. alone and/or in clusters). The numbers and phenotypes of any rare cells present will be evaluated for association with the patient disease state (e.g., study group), the presence of metastatic disease as determined by NGI, and disease progression and/or survival (for up to two years following enrollment).

DNA and/or RNA will be isolated from the population of cells captured from the peripheral blood samples by the Parsortix system and will be evaluated using molecular methods (e.g. multiplex gene expression, mutational analysis, sequencing, etc.) to determine the genotype(s) of the harvested cells. The genotype(s) of any rare cells present will be evaluated for association with the patient disease state (e.g., study group), the presence of metastatic disease as determined by NGI, and disease progression and/or survival (for up to two years following enrollment).

MidLantic Urology, LLC

Angle plc

All patients receiving SOC imaging and Axumin PET scans.

Fluciclovine is a radiotracer that will be used in conjunction with the high resolution digital Vereos PET/CT scanner.

Fluciclovine PET/CT using a digital PET/CT

Fluciclovine F18 (Axumin) has been demonstrated to provide good delineation of recurrence of prostate cancer after definitive therapies. Fluciclovine in conjunction with the high-resolution digital Vereos (Phillips) PET-CT scanner may detect low volume recurrence in the prostatectomy bed or metastatic site (s).

20-40 % of men will suffer a biochemical recurrence of their prostate cancer after radical prostatectomy, depending on their final pathological staging, defined as a rising PSA \> 0.2 ng/ml.

The ability to more accurately diagnose local recurrence (i.e. pelvis) or oligometastasis may lead to the opportunity of precise therapy of these sites with more durable cancer responses, less morbidity and potential cure in selective men after Radical Prostatectomy.

The ability to diagnose widespread metastatic Prostate Cancer after Radical Prostatectomy, or disease that is inaccessible to local selective therapies would spare these men the cost and morbidity of inappropriate therapy.

The diagnosis of true stage D0 Prostate Cancer (No objective evidence of metastases) in men after Radical Prostatectomy would yield improved overall and disease specific survival if Androgen Deprivation Therapy was initiated at its earliest stage. This would also obviate the need for inappropriate local therapies (i.e. pelvic radiotherapy).

The aim is to compare the detection rate of standard of care (CT Pelvis/Abdomen, MR Pelvis, Bone Scan) with Fluciclovine PET/CT performed on the Vereos Philips Scanner. The study aims to compare the performance of Digital (high resolution) PET to CT/MRI/Bone scan rather than analog (lower resolution) PET. Prior studies have tested analog PET compared to other modalities. One could make an inference that if our study's Digital PET performs better than the performance of Analog PET in those studies, then Digital PET should have a better detection rate than Analog PET. However, investigators are not making a direct comparison between digital and Analog in our comparison.

Aim:

Compare the detection rate of standard of care (CT Pelvis/Abdomen, MR Pelvis, Bone Scan) with Fluciclovine PET/CT performed on the Vereos Philips Scanner. The study aims to compare the performance of Digital (high resolution) PET to CT/MRI/Bone scan rather than analog (lower resolution) PET. This was reported in Michopoulou S, O'Shaughnessy E, Thomson K, Guy MJ. Discovery Molecular Imaging Digital Ready PET/CT performance evaluation according to the NEMA NU2-2012 standard. Nucl Med Commun. 2018 Nov 27; doi:10.1097/MNM.0000000000000962. Prior studies have tested analog PET compared to other modalities. One could make an inference that if our study's Digital PET performs better than the performance of Analog PET in those studies, then Digital PET should have a better detection rate than Analog PET. However, investigators are not making a direct comparison between digital and Analog in our comparison.

Background:

Fluciclovine F18 (Fluciclovine) has been demonstrated to provide good delineation of recurrence of prostate cancer after definitive therapies (Odewole OA et al 2016). Fluciclovine in conjunction with the high-resolution digital Vereos (Phillips) PET-CT scanner may detect low volume recurrence in the prostatectomy bed or metastatic site (s).

20-40 % of men will suffer a biochemical recurrence of their prostate cancer after radical prostatectomy, depending on their final pathological staging, defined as a rising PSA \> 0.2 ng/ml.

The ability to more accurately diagnose local recurrence (i.e. pelvis) or oligometastasis may lead to the opportunity of precise therapy of these sites with more durable cancer responses, less morbidity and potential cure in selective men after Radical Prostatectomy.

The ability to diagnose widespread metastatic Prostate Cancer after Radical Prostatectomy, or disease that is inaccessible to local selective therapies would spare these men the cost and morbidity of inappropriate therapy.

The diagnosis of true stage D0 Prostate Cancer (No objective evidence of metastases) in men after Radical Prostatectomy would yield improved overall and disease specific survival if Androgen Deprivation Therapy was initiated at its earliest stage. This would also obviate the need for inappropriate local therapies (i.e. pelvic radiotherapy).

Preliminary Studies:

The safety, efficacy, reproducibility, and reliability of Fluciclovine was initially evaluated by the Emory group in men with suspected recurrence of prostate cancer based on rising PSA levels following radical prostatectomy and/or radiotherapy. Fluciclovine's safety, detection rate, and diagnostic performance was further validated in a multi-site data aggregation study using data from Emory, Noway, and Italy.

The performance of Fluciclovine seems to be affected by degree of PSA elevation. Statistically significant difference in performance compared to CT was found at PSA levels \>1 ng/ml. However, at a PSA level of \<1 ng/ml, no statistically significant difference was found by Odewole et al. These findings were independent of PSA doubling time and Gleason Score.

The Bologna study evaluated the concordance between Fluciclovine and C11 Choline scans in patients with median PSA value of 1.44 ng/ml (interquartile range = 0.78 to 2.8 ng/ml).5 The accuracy of Fluciclovine was 38% vs 32% for C11 Choline. In a subsequent Emory study which studied Fluciclovine without a correlative imaging test, Fluciclovine scan detected recurrence in 72% (18/25) of patients with PSA of \<1 ng/ml. However, there was no reconciliation of false positive examinations, as all abnormal radiotracer uptake were deemed a true positive. Performance of Fluciclovine was again noted to improve with increasing PSA levels, at 83% (5/6) for PSA of 1-\<2 ng/ml and 100% (11/11) for PSA\>= 2 ng/ml.

Rationale:

A Fluciclovine scan can detect and localize recurrent prostate cancer. Fluciclovine is an FDA-approved diagnostic imaging agent, also known as a "tracer," which may help determine if and where the prostate cancer has recurred.

Procedures:

Fluciclovine is used as a tracer for a PET/CT scan. Patients will need to prepare for the Fluciclovine (fluciclovine F 18) injection and scan. They will need avoid any significant exercise for at least a full 24 hours prior to Fluciclovine PET/CT scan and not eat or drink for at least 4 hours prior to PET/CT scan (other than small amounts of water for taking medications).

With respect to determining if a finding is true positive, investigators will follow the following process. The research PET scan of each patient and SOC imaging will be read by radiologists blinded to the results of the other test. The results of both will then be reviewed by PI for concordance. If the research PET scan finds sites of disease that were not identified on SOC imaging, the case will be brought to Interdisciplinary UVMMC Genitourinary tumor board. Depending on the site of disease and presence of other concordant sites of metastatic disease between scans, it may have no impact on the SOC treatment. If it is deemed by the UVMMC Genitourinary Tumor Board that it will have a meaningful impact on treatment decisions and the detected lesion is accessible to be safely sampled, the patient will be approached by their treating physician to discuss the discordant findings, their significance, and the rationale behind a biopsy and its impact on their care.

The sampling will then be performed a part of standard-of-care work-up, given that these patients would have been eligible for Fluciclovine PET imaging in this setting, per FDA label. Given the low PSA range of our target population in this study, the likelihood that these lesions would be amenable to sampling using conventional image guidance is low. Therefore, in cases where the research scan finds additional disease that would alter therapy, the decision of whether to act on it will be based on the overall clinical scenario of each patient, and will be decided by the treating team with the support of the UVMMC Genitourinary Tumor Board.

Determination of the Diagnostic Detection Rate of Axumin (Fluciclovine) Digital PET/CT, Post-prostatectomy

Determination of the Diagnostic Detection Rate of Axumin (Fluciclovine) PET/CT Utilizing the High Resolution Digital Philips Vereos Scanner, in Patients With Biochemical Recurrence After Radical Prostatectomy

Comparison of Fluciclovine digital PET/CT with standard of care imaging. Single time point.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Role of Axumin PET Scan in Germ Cell Tumor	NCT03426865	Testis Cancer Germ Cell Tumor Testicular Canc... Germ Cell Tumor... Germ Cell Tumor... Testicular Neop... Testicular Germ... Testicular Yolk... Testicular Chor... Testicular Dise... Germ Cell Cance... Germ Cell Neopl... Germ Cell Cance...	Axumin PET scan	18 Years -	University of Texas Southwestern Medical Center
Defining Recurrent Disease With Axumin™	NCT03996993	Prostate Cancer Prostate Adenoc...	Casodex, Axumin Salvage Radiati...	18 Years -	Cancer Center of Irvine
Defining Recurrent Disease With Axumin™	NCT03996993	Prostate Cancer Prostate Adenoc...	Casodex, Axumin Salvage Radiati...	18 Years -	Cancer Center of Irvine
Characterization of Circulating Tumor Cells (CTCs) in High Risk and Early Metastatic Prostate Cancer Patients Using Parsortix® System	NCT05437679	High Risk Prost... Biochemically R... Castration-resi... Prostate Cancer	Blood collectio...	18 Years -	Angle plc
Determination of the Diagnostic Detection Rate of Axumin (Fluciclovine) Digital PET/CT, Post-prostatectomy	NCT04234399	Prostatic Neopl...	Fluciclovine PE...	40 Years -	University of Vermont

Spots Global Cancer Trial Database for axumin

Every month we try and update this database with for axumin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for axumin

Every month we try and update this database with for axumin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for axumin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.