View clinical trials related to Prostatic Neoplasms.
Filter by:TITLE Timing of HDR brachytherapy with EBRT in intermediate and high risk localised Prostate CAncer patients and its effects on Toxicity and Quality of life - randomised feasibility trial. SHORT TITLE THEPCA trial Protocol Version Number and Date Version 2.1, dated 16 DEC 2014 Study Duration Recruitment Duration 18-24 months Study Centre Southend University Hospital NHS Foundation Trust Objectives Assessment of acute toxicities: Genitourinary, gastrointestinal and sexual dysfunction at various time points. Number of Participants 50 participants Main Inclusion Criteria - Patient age >18 years - Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0 - Any Gleason score - Any PSA level - Patient able to consent and fill in the questionnaires Exclusion Criteria - Previous TURP/HoLEP Laser Prostatectomy - Any Metastatic Disease - IPSS>20 - Pubic arch interference - Lithotomy position or anaesthesia not possible - Rectal fistula - Prior pelvic radiotherapy Statistical Methodology and Analysis Percentages of adverse events will be compared using Fisher's Exact Test. Toxicity score means will be compared using two-sample permutation t-tests, and PSA relapse-free survival will be estimated using Kaplan-Meier and compared using log-rank tests.
99mTc-MIP-1404 is a radioactive diagnostic imaging agent indicated for imaging men with newly diagnosed prostate cancer whose biopsy indicates a histopathologic Gleason Score of ≤ 3+4 severity who are candidates for active surveillance and are undergoing voluntary radical prostatectomy (RP) [Cohort A] or routine prostate biopsy [Cohort B]. This Phase 3 study is designed to evaluate the specificity and sensitivity of 99mTc-MIP-1404 SPECT/CT imaging to correctly identify subjects with previously unknown clinically significant prostate cancer.
Obesity and metabolic syndrome are prevalent among prostate cancer patients. Having an elevated insulin level in the blood is associated with a shorter median time to cancer progression and median overall survival in patients with an elevated PSA after prior treatment. Androgen deprivation therapy (ADT) with drugs like bicalutamide is frequently used in this patient population,with no proven benefit, which may increase mortality and morbidity.This study evaluates how metformin in combination with bicalutamide affects prostate cancer.
This Phase II, open-label, three-arm randomized controlled trial (RCT) will investigate the effects of 12 weeks of aerobic exercise vs. 12 weeks of resistance exercise vs. usual care in men with metastatic castration resistant prostate cancer to determine the safety, feasibility, and tolerance of exercise; quality of life indicators, and a prognostic score.
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68 HBED-CC PSMA) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy, patients with biochemical recurrence and patients with castrate resistant prostate cancer.
This pilot phase I trial studies copper Cu 64 TP3805 (Cu-64-TP3805) positron emission tomography (PET)/computed tomography (CT) in detecting cancer in patients with prostate cancer undergoing surgery to remove the entire prostate and some of the tissue around it (radical prostatectomy). Many patients with benign lesions must undergo biopsy to test the lesion. Cu-64-TP3805 is a radioactive substance that attaches to cancer cells but not normal cells. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body where the radioactive substance is lighting up. Using Cu-64-TP3805 PET/CT scans and comparing them with cancer tissue obtained from surgery may help doctors learn whether Cu-64-TP3805 PET/CT can accurately detect prostate lesions and determine whether they are cancerous or benign, which may minimize the need for prostate biopsies.
This phase II trial studies how well nivolumab and ipilimumab work in treating patients with hormone-resistant prostate cancer that has spread to other places in the body and express androgen receptor-variant-7 (AR-V7). Tumor cells expressing AR-V7 has been shown to be resistant to hormone therapy and some chemotherapy in patients with prostate cancer. Biomarker-driven therapy, such as nivolumab and ipilimumab, may work by blocking key biomarkers or proteins that help tumor cells to escape the immune system surveillance and this may help the immune system to kill tumor cells that express AR-V7.
This pilot clinical trial studies docetaxel and carboplatin in treating patients with castration resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic) and contains inactivated genes in the BRCA 1/2 pathway. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
The purpose of this study is to investigate the efficacy and safety of enzalutamide in patients with non-metastatic castration resistant prostate cancer. The total duration of the study will be 5 years. All patients will receive enzalutamide 160 mg (four 40 mg capsules) orally once daily. The treatment will be started at Visit 0 within one week after enrollment. Visit 1 is at 2 weeks after the treatment started; clinical assessments are conducted on adverse events and the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales. Patients who are considered to be adequate by the investigator can continue the treatment with 12-week cycle visit (counted from initial dose) until patients meet withdrawal criteria. Patients will be followed up at 2 and 3 years after enrollment and at 3 years after the last participant enrollment. The end of the study is defined as follow-up assessment date at 3 years after the last participant enrollment. Patients will primarily be assessed by prostate-specific antigen (PSA) progression-free survival (PFS).
Our aim is to develop a new diagnostic approach to improve the diagnosis of men suspicious of having significant prostate cancer (sPCa). The current diagnostic technique (standard transrectal ultrasound-guided biopsies [TRUS-bx]) rely on multiple prostate biopsy cores (10-12 samples) and if negative repeated biopsy sessions. This increases both patient complications (severe infections, bleeding and anxiety) and the diagnosis of insignificant cancer causing overtreatment. Still, significant cancers are missed. In addition, worldwide antibiotic-resistant bacteria increase, while effective antibiotics are declining. Thus, a noninvasive diagnostic tool to improve selection of men with clinically suspicion of PCa who need a biopsy from those who can avoid one is strongly needed. Previous studies in our department show that MRI in a selected patient cohort with prior negative TRUS-bx can improve the detection rate of clinically significant PCa and allows for a more accurate assessment of cancer stage and aggressiveness. However, the value of an MRI used as a first-line tool in the diagnostic examination of men in suspicion of PCa is uncertain. Furthermore, a full scale MRI prostate examination recommended by the European Society of Urogenital Radiology includes intravenous contrast-media and multiple sequences. This is both time-consuming and cost full, which reduces its feasibility for more widespread clinical implementation. We believe that a simpler, faster biparametric MRI (bpMRI) using less scan sequences and circumvents intravenous contrast-media and anti-peristaltic drugs would decrease image acquisition time, reduce costs and is sufficient to preserve diagnostic accuracy for sPCa detection in biopsy-naive men. Consequently, we will include biopsy-naive men in a protocol-based research project. The objective is to assess the diagnostic accuracy of bpMRI to rule out sPCa and whether a bpMRI can be used as a diagnostic non-invasive screening tool to 1) improve the diagnosis of sPCa 2) assess cancer aggressiveness 3) increase precision of biopsies and 4) reduce the number of biopsy sessions and cores. We evaluate the clinical significance of the detected cancers and whether bpMRI could be used as a triage test to improve the diagnosis of sPCa and aid in the determination of which men could safely avoid unnecessary biopsies. This new diagnostic approach has the potential to significantly reduce patient hazards and complications. We aim to reach 1000 included men. We believe that bpMRI used in the clinical decision-making has the potential to change the future management of PCa. However, we still miss the scientific evidence to substantiate its preliminary promising results before this technique can be widely used to benefit all men. This large research project is to the best of our knowledge powered to include the largest patient sample size published within this field.