Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade...
Prostate CancerThis study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The radiation will be given for only 5 days. The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy.
Soccer Intervention in Prostate Cancer Survivors
Prostate CancerThis study seeks to directly test the implementation feasibility of a soccer-based and lifestyle education intervention to determine the effects on bone health, body composition, mental health, functional and cardiometabolic status among prostate cancer survivors.
High Resolution MRI Study for Prostate Cancer
Prostate CancerThis high resolution MRI (hrMRI), along with stand MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance. Changes in lesion size and ADC values will be assessed on the serial studies. This study evaluates the hypothesis that hrMRI will detect changes that sMRI cannot detect and that these changes will correlate with prostate cancer progression as determined on prostate biopsy.
Ga-68-PSMA-11 in High-risk Prostate Cancer
High-risk Prostate CancerProstate Cancer2 moreThis will be an open-label, single-arm, rater-blinded, multicenter, diagnostic phase 1/2 study to assess safety and diagnostic performance of Ga-68-PSMA-11 positron emission tomography / computer tomography (PET/CT) imaging to detect tumour tissue in patients with newly diagnosed PCA and a high risk for metastasis. As standard of truth, comprehensive histopathology covering prostate and the tributary pelvic lymph node system, will be used. Therefore, only patients scheduled for RP with EPLND (as part of their standard of care) will be eligible. Patients will be recruited at up to 11 uro-oncological sites in Germany, Austria, and Switzerland, with access to a radiopharmaceutical laboratory, experienced to prepare 68Ga-labelled compounds, and high-quality PET/CT imaging. Upon histological confirmation of PCA, pre-operative staging will be performed according to European Association of Urology (EAU) guideline [Mottet et al. 2015] (to include pelvic MRI or CT and a 99mTc-bone scan), to establish the indication for RP with EPLND. If the indication is confirmed, patients will be invited to participate in the present study. After consenting, review of inclusion and exclusion criteria, as well as screening investigations will be performed by the uro-oncologist (day 0). Thereafter, patients are referred to the collaborating nuclear medicine department for tracer injection, imaging, and post-dose safety evaluations (day 1). Subsequent investigations (day 2 and at end of study) will be made by the uro-oncologist or experienced nuclear medicine physician. Study participation ends on day 7. Routine surgery (RP with EPLND) will be performed after end of study, but no later than 42 days after study inclusion. This sequence allows adequate characterisation of tracer safety, while at the same avoiding unnecessary delay of, or confounding safety signals from therapy. In total, 150 evaluable patients will be included to receive a single 68Ga dose of 150 MBq (± 50 MBq), administered as i.v. infusion. Due to an assumed dropout rate of 15%, up to 173 patients will be included in study.
Evaluating the Impact of Evidence-based Information About PSA Testing on Prostate Cancer Screening...
Prostate CancerPatient decision aids are tools that help guide individuals through a healthcare-related decision making process. They help users combine evidence-based information and recommendations by a health care provider with their personal needs, values and preferences. Through this project, Dr. Dobbins and her research team will explore whether the use of patient decision aids with high-quality and user-friendly summaries of research evidence, or summaries of research evidence alone, help to improve the quality of decision making by men facing prostate cancer screening decisions.
Apalutamide With Radiotherapy and Androgen Deprivation Therapy in Prostate Cancer
Prostate CancerThe main objective of the trial to determine if the combination of apalutamide with 6 months of androgen deprivation therapy by LHRH agonists in patients with intermediate and limited high-risk, localized prostate cancer receiving primary radiation therapy (RT) results in an improvement of disease-free survival (DFS) evaluated by the treating physician, in comparison to the combination of radiation and androgen deprivation therapy without the addition of apalutamide.
Ga-68 PSMA Ligand: A Radiopharmaceutical for Localization of Prostate Cancer
Latent Cancer ProstateThis is an open-label single arm clinical trial, plan to enroll approximately a total of 62 evaluable subjects. According to the estimated missing rate 15%, the sample size in this study is 73. Inclusion criteria: To be eligible for inclusion, each patient must fulfill all of the following criteria: Age equals or more than 20 years old Willing to sign the informed consent Pathology-proved intermediate to high risk group prostate cancer patients (PSA > 10 ng/mL, or Gleason score 7-10, or clinical stage >T2a) OR Prior radiotherapy or prostatectomy for prostate cancer with biochemical recurrence defined as: post prostatectomy: increase in PSA of > 0.2 ng/mL in two or more consecutive blood samples post radiotherapy: PSA levels of ≥ 2 ng/mL above the post-therapy nadir Life expectancy more than 3 months Exclusion criteria: Patient who has any of the following criteria will be excluded from the trial: Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable. With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast Unable to give informed consent. Allergy history to Ga68-PSMA ligand, significant abnormal lab data (ALT more than three times of normal value), and high risk to conduct examination after evaluations of PI. Patient had malignancy history
Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells
Prostate CancerRuxolitinib will be dispensed to patients candidate to prostatectomy immediately after histological diagnosis of prostate adenocarcinoma. The treatment will be given for 28 days followed by a prostatectomy thereafter. Tumor material and blood samples will be analysed before, during and after the treatment with Ruxolitinib.
TransPERineal Fusion Biopsy Versus transrECTal
Prostate CancerComparison of the efficacy and safety of 2 types of prostatic biopsies: transperineal biopsy versus transrectal biopsy.
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC
Prostate CancerProstatic Cancer6 moreNUV-422-04 is an open-label Phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with enzalutamide. The study population is comprised of adults with mCRPC. Patients will self-administer NUV-422 and 160 mg enzalutamide orally in 28-day cycles. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.