View clinical trials related to Prostatic Adenocarcinoma.
Filter by:Although surgical or medical castration (i.e., androgen-deprivation therapy, ADT) is considered standard treatment in metastatic castration-naïve PC (mCNPC) patients, current guidelines have established the addition docetaxel or modern androgen receptor targeting agents (ARTAs; abiraterone acetate or enzalutamide) to ADT as the standard of care for patients with mCNPC [1,2]. One of the major challenges in the management of mCNPC includes balancing the toxicity of first-line docetaxel with clinical benefit. Our previous clinical studies suggested that the tolerability of docetaxel could be improved by using a biweekly regimen [3,4], without compromising efficacy. There is a growing interest in maintenance therapy as a strategy for prolonging the benefit of first-line therapy while minimizing long-term toxicity. In phase III trials involving first-line enzalutamide in mCNPC (ENZAMET and ARCHES), earlier treatment with docetaxel was permitted [5,6]. Based on these considerations, we hypothesized that enzalutamide maintenance therapy would improve outcomes in patients who had received first-line biweekly docetaxel plus ADT for mCNPC.
Phase 2 open-label, single-arm clinical trial evaluating the efficacy and safety of neoadjuvant olaparib + LHRH agonist administered for 6 months prior to radical prostatectomy (RP) in men with unfavorable intermediate-risk or high-risk localized prostate cancer. All patients must have confirmed germline or somatic BRCA1/2 gene mutation. Germline and somatic mutation testing will be performed as part of commercially available CLIA assays and will be validated on a uniform platform centrally all patients retrospectively. Eligible patients will receive treatment with olaparib + LHRH agonist. Following 6 months of therapy, patients will undergo RP with mandatory lymph node dissection. The lymph node dissection template will be at the discretion of the treating urologist. RP specimens will undergo pathology blinded independent central review. Following RP, patients will be followed for testosterone recovery and PSA progression.
With 50% of post-operative biochemical failure, efficient predictive models are needed to guide post-operative management. Radiomic features are quantitative features extracted from medical imaging, supposed to be correlated with tumor heterogeneity. We aim to build and test three predictive models (clinical, radiomic and combined models).
Gold markers implanted in the prostate are used frequently for position verification of the prostate during external-beam radiotherapy. By using the markers as a surrogate for the prostate itself, not only set-up errors, but also the internal motion of the prostate relative to the bony anatomy can be identified. It is thus believed that escalated dose marker guided radiotherapy should result in better biochemical control compared to conventional external beam radiotherapy, with a similar or lower incidence of toxicity. However, clinical data to support this is still limited. The purpose of this study is to directly compare late toxicity as well as biochemical control between patients treated with dose escalated marker guided radiotherapy versus conventional dose non-marker guided radiotherapy who has otherwise been treated with similar radiotherapy planning techniques and equipment. Prostate magnetic resonance imaging has undergone several technical improvements and shows promises for prostate tumor detection and localization. In addition to morphological information, magnetic resonance imaging allows an estimation of physiological properties of tissues. Diffusion-weighted magnetic resonance imaging is sensitive to restriction of diffusion of water molecules, and dynamic contrast enhanced magnetic resonance imaging can analyze tissue micro vascular properties. Multi para metric magnetic resonance imaging combining Diffusion-weighted and Dynamic contrast enhanced has demonstrated its value in distinguishing malignant from benign prostate tissue. Higher radiation dose levels were consistently associated with improved biochemical control outcomes and reduction in distant metastases. Radiation dose was one of the important predictors of long-term biochemical tumor control. Dose levels < 70.2 Grey and 70.2-79.2 Grey were associated with 2.3 and 1.3-fold increased risks of pro static specific antigen relapse compared with higher doses. However, further dose escalation to the whole gland is limited due to an unacceptable high risk of acute and late toxicity. Moreover, local recurrences often originate at the location of the macroscopic tumor, so boosting the radiation dose at the macroscopic tumor within the prostate might increase local control. A reduction of distant metastases and improved survival can be expected by reducing local failure. Treating the dominant focus or boosting the dose to this area while reducing the dose to as much healthy tissue as possible has significant potential for improving treatment.
The present randomized, open, multicentric Phase II trial, in parallel groups with two arms of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate. Ninety-six patients and 9 centers are included in the protocol.
Degarelix is an approved drug that is used to treat prostate cancer by lowering testosterone levels in the body. Degarelix is commonly given with radiation for prostate cancer, but less frequently with surgery since there has been no proven benefit with this approach. The investigators do not expect the patient to benefit directly from treatment with degarelix since their prostate will be removed shortly after the drug is given. Instead, the investigators hope to learn about how degarelix and other treatment that lowers your testosterone effects prostate cancer cells and use this information to develop better treatments in the future.
The main purpose of this study is to determine whether ADT started before or after sipuleucel-T leads to a better immune system response. This study will also evaluate the safety of sipuleucel-T treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.