View clinical trials related to Prostatic Neoplasms.
Filter by:Previous studies of high dose testosterone therapy given intramuscularly to men with metastatic castrate resistant prostate cancer suggest that high serum levels of testosterone may be required for clinical response. This injection regimen was given as one dose of 400mg injection every 28 days, which initially produces high serum testosterone levels but these levels drop to a varying degree in some men over the 28-day cycle. In this 30 patient trial will analyze the effects of oral testosterone therapy in men with metastatic castrate resistant prostate cancer taken on a schedule of seven days of oral testosterone therapy followed by seven days of no therapy for a twenty-eight day cycle. This therapy will be given for three 28 day cycles consecutively followed by radiographic scans to evaluate the metastatic disease. Patients will be allowed to continue on this therapy until the patients show signs of radiographic progression. If the patients show signs of radiographic progression after the first three cycles, the patients will stop taking the oral testosterone therapy and begin taking enzalutamide therapy. Enzalutamide therapy will be taken for three 28 day cycles, then radiographic scans will be taken. If there are no signs of radiographic progression, patients can continue to take enzalutamide therapy for an additional 3 cycles while on study. Patients with continued PSA or objective response will come off study but continue on enzalutamide as standard of care therapy. This study will help the investigators to understand if treating these men with the highest FDA approved dose of oral testosterone therapy will achieve similar and sustained high levels of serum testosterone that will produce similar or enhanced therapeutic response to the therapy when compared to the serum testosterone levels found in the previous injection therapy trials.
The skeleton is the most frequent organ of distal metastases in prostate cancer, often representing the only site of metastatic disease. Still, assessment of response and progression to therapies in bone metastases remains a major unmet need, to aid treatment switch decisions, detecting primary/secondary resistance and to optimize drug development. The currently used standard imaging techniques, computed tomography (CT) and bone scintigraphy (BS), do not depict the true extent of bone metastases and are suboptimal in capturing biological changes occurring in response to treatment. This results in treatment switch decisions too often being based on PSA changes, which is neither a surrogate of survival, nor an optimal response biomarker.Diffusion-weighted imaging (DWI) is a functional magnetic resonance imaging (MRI) technique that studies the movement of water molecules within a tissue and provides valuable information about the tissue microstructure and cellularity. Whole body MRI with DWI is highly accurate for bone metastases detection, outperforming the standard CT and BS and other imaging techniques when assessing bone metastases. The investigators hypothesise that DWI changes are a response biomarker in bone metastases from metastatic castration resistant prostate cancer (mCRPC); these DWI changes can be detected as early as after 4 weeks of systemic treatment.
Primary Objective: - To evaluate the safety and tolerability of ADXS-504 and to determine the MTD (maximum tolerated dose) or RP2D (recommended phase two dose) Secondary Objectives: - To characterize the immunological activity of ADXS-504, administered as; and to characterize the genomic profiles of study subjects - To evaluate the effects of ADXS-504 on change in PSA - To evaluate time to PSA progression
This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy（ADT）for High risk prostate cancer ，This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,
This is a Phase 1/2 study of EPI-7386 orally administered in combination with enzalutamide in subjects with mCRPC. Phase 1 of the study will be a single-arm dose escalation study of EPI-7386 in combination with a fixed dose of enzalutamide. This portion of the study will primarily evaluate the safety and tolerability of the drug combination and establish the RP2CDs for EPI-7386 and enzalutamide when dosed in combination. In addition, blood sampling will be conducted for PK evaluation to assess the potential DDI between the two drugs. Once the RP2CD for each drug has been established, Phase 2 of the study will commence. Phase 2 is a two-arm, randomized (2:1), open-label study. Approximately 120 subjects will be randomized 2:1 to: - Group 1: EPI-7386 at the RP2CD + enzalutamide(depending on the results of the Phase 1) (n=80) - Group 2: Enzalutamide single agent (n=40) The planned dose of enzalutamide and EPI-7386 for the combination arm will be those determined in the Phase 1 of this study based on safety and exposure data. Subjects may remain on study treatment as long as they are tolerating treatment without disease progression based on RECIST v1.1 and/or PCWG3.
Patients with primary low and intermediate risk prostate cancer (PCa) for whom radical prostatectomy are indicated, will be invited to participate to the present study. The aim of this study is to investigate the clinical value of 68Ga-GRP positron emission tomography / computed tomography (PET/CT) compared to 68Ga-PSMA PET/CT in patients with low and intermediate risk PCa.
Hot flashes are a common and debilitating symptom among prostate cancer patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that venlafaxine provides partial relief, but the tolerability is poor when the dose is not tapered. Hence, an alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence.
Postoperative delirium（POD）is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. In order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. The efficiency and safety of neuroleptanalgesia on the incidence of POD would be evaluated in elderly patients.
This phase II trial investigates the effect of massage in decreasing prostate cancer-related fatigue. Massage therapy has well known health benefits. This trial aims to find out if massage and touch therapies reduce fatigue due to cancer, and to learn if these therapies are better than traditional medicine or psychology for cancer related fatigue.
A Phase 1/2 study to evaluate the safety and efficacy of ARV-766 given by mouth alone or in combination with abiraterone in men with metastatic prostate cancer.