68Ga-PSMA PET/CT in Prostate Cancer
Prostate CancerThis is a single-center, multi-arm, open-label, phase III trial in up to 500 patients with biopsy-proven prostate cancer. Participants will receive regular standard of clinical care. The only study-specific procedures will the administration of 68Ga-PSMA-11 followed by a PET/CT (positron emission tomography/computed tomography) scan. Participants will be followed for two hours after the infusion for identification of any immediate adverse events (AE), and will be contacted by telephone after 7 to 14 days to enquire about any delayed AEs. PET/CT images, CT-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. The standard of truth will be a consensus of the readers based on all available clinical, imaging, and histopathological information available for up to 6 months after the PET/CT scan.
Extended Systematic Versus Mri-Assisted pRostate Transperineal Biopsy
Prostate CancerThis is a randomized controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-targeted approach (MRI-arm) versus 24-core transperineal (TP) systematic biopsy (TP-arm). Clinically significant prostate cancer (csPCa) is defined as ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer. Patients with elevated PSA 4-20 ng/mL with or without abnormal digital rectal examination (DRE) will be randomized in a 1:1 manner to MRI-arm or TP-arm. In the MRI-arm, multiparametric MRI prostate will be performed for each subject. MRI prostate is considered abnormal if PI-RADS (Prostate Imaging-Reporting and Data System, version 2.1) score is 3, 4 or 5. For subjects in MRI-arm with abnormal MRI, MRI-targeted biopsy will be performed, followed by 12-core systematic transperineal biopsy (sparing MRI-target). For subjects in MRI-arm with normal MRI, no biopsy is performed. For subjects in TP-arm, 24-core systematic transperineal biopsy will be performed without MRI guidance. The study flowchart is provided in Figure 1. The detection rates of csPCa will be compared between MRI-targeted biopsy plus 12-core systematic biopsy (in MRI-arm) versus TP-arm. The study hypothesis is MRI-guided prostate biopsy with 12-core systematic biopsy is superior to 24-core transperineal systematic biopsy in detection of csPCa.
Study of Diagnostic Performance of [18F]CTT1057 in BCR
Prostatic NeoplasmsProstate Cancer1 moreThe current study aims at evaluating the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positivity in patients diagnosed of biochemical recurrence of prostate cancer (PCa), using a composite truth standard. Approximately 190 participants will be enrolled to ensure at least 152 participants are evaluable (i.e. have both an evaluable [18F]CTT1057 PET/CT scan imaging, and at least one evaluable CTS assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures), which will be required for the calculation of the co-primary endpoints.
Diet and Exercise Interventions Among Men With Prostate Cancer (Prostate 8-II)
Prostate CancerThe Prostate 8-II study is a randomized controlled trial of testing different combinations of educational and supportive tools related to diet and exercise to evaluate biological, clinical, and quality of life outcomes in men choosing radical prostatectomy as treatment for prostate cancer.
Evaluating the Role of Ultrasound in Prostate Cancer
Prostate CancerActive surveillance (AS) is becoming an increasingly common treatment option for men who have been diagnosed with localised low-grade prostate cancer (PCa). Low-grade disease is commonly noted by clinicians to be clinically insignificant cancer but remains a psychological burden to many men in this cohort. There is consensus that regular review is required for men on AS so that early treatment can be undertaken if there is disease progression, and to support men living with a cancer diagnosis. Some AS protocols, including National Institute for Clinical Excellence (NICE), advocate the use of MRI as a regular part of the monitoring pathway. Unfortunately, access to MRI for AS, within the current health care environment in the UK, is limited due to increasing demand for primary diagnostic examinations, particularly in the post pandemic recovery phase. Emerging technologies in ultrasound imaging may, however, add another diagnostic tool to monitor disease for patients on AS. This proof of concept study is to evaluate whether new multi-parametric ultrasound techniques can safely reduce the number of MRIs required for effective AS. Men being investigated for PCa will be invited to undergo an ultrasound examination of their prostate, via the rectum, in addition to the diagnostic MRI undertaken as part of normal care. The findings of the ultrasound will be directly compared with the MRI and any subsequent biopsy samples taken as part of routine care. Those who then progress onto AS will be invited to undergo regular rectal prostate ultrasound examinations. These will be compared with previous imaging for signs of change. This study will also evaluate the changing role of practitioners who will be using new technologies and making decisions about disease progression. The ability to implement new techniques will be assessed. All imaging will be undertaken at Castle Hill Hospital over a 24-month period from commencement of the study.
Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer...
Prostate CancerDespite the recognized benefits of physical activity in tertiary prevention, 60-70% of prostate cancer patients are insufficiently active. Yet 150 minutes of brisk walking per week (new WHO recommendations) is associated with a 29% reduction in cancer mortality and a 57% reduction in recurrence. Increasing patients' adherence to regular physical activity appears to be a new challenge for personalized cancer care. Personalized physical activity programmes (1) at home, (2) supported by health professionals, or (3) by peers have shown the effectiveness of regular physical activity. However, these interventions last less than 6 months and do not allow for long-term sustainability of physical activity. This study proposes to combine 3 interventions, which aim to initiate and maintain regular physical activity in prostate cancer patients: 1-The realization of a personalized and realistic physical activity project via physical activity support devices (sport health centers) 2-Coaching by a peer (a patient with the same disease who has reached the WHO recommendations for physical activity), who will provide motivational follow-up 3-Support by health professionals (attending physician) through the prescription of physical activity. The feasibility of ACTI-PAIR program has been demonstrated, the investigators now wish to evaluate it effectiveness.
Clinical Utility of MyProstateScore 2.0 P2
Prostate CancerThis is an extension of an ongoing study. Preliminary results from the ongoing study indicate that the MyProstateScore 2.0 (MPS 2.0) Test is significantly improving early diagnosis of prostate cancer. This extension will allow us to ask the study participants in the ongoing study to share patient-level data for chart abstraction. The specific purpose of this study is to generate high-quality real-world data on the clinical utility of LynxDx's new MPS 2.0 test.
Assessment of Research Digest Impact for Minority With Prostate Cancer, MiCAP Phase III Study
Prostate CarcinomaThis phase III trial determines how well the Minority Prostate Cancer (MiCaP) Research Digest works in providing information to black men about the latest prostate cancer research. MiCaP Research Digest may be an effective method to help people learn about prostate cancer.This goal of this trial is to create educational programming that helps Black men make informed decisions about their prostate healthcare since Black men are diagnosed with prostate cancer more than any other race or ethnicity.
64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)
Biochemical Recurrence of Malignant Neoplasm of ProstateThe aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with PSMA-negative biochemical recurrence of prostate cancer following definitive therapy.
99mTc-P137 SPECT/CT in Prostate Cancer
Prostate CancerPurpose: This study will take prostate specific membrane antigen (PSMA) as the targeting of radionuclide labeled molecular probe to explore the diagnostic efficacy of 99mTc-P137 radioactive probe in prostate cancer. Combining with SPECT/CT to optimize the imaging, image analysis and clinical diagnosis process of 99mTc-P137 probe, the aim of the study is to provide new methods and new means for the early detection, early diagnosis, accurate tumor staging, treatment decision and prognosis judgment of malignant tumor, and will provide scientific and clinical basis for the precise diagnosis and treatment of prostate cancer. Research objectives: To investigate the clinical translational application value of 99mTc-P137 molecular probe in accurate detection of prostate cancer lesions. Research design: A prospective study design will be used in this study. Patients meeting the inclusion criteria of this study will be analyzed with 99mTc-P137 SPECT/CT imaging. To evaluate the diagnostic and prognostic value of 99mTc-P137 nuclear medicine imaging in accurate detection of prostate cancer lesions, clinical surgical specimens and pathological diagnosis will be used as the gold standard. Study the population Indications: For patients with suspected prostate cancer who plan to undergo surgical resection or puncture biopsy after various examinations, the final pathological results can be obtained.