Active clinical trials for "Prostatic Neoplasms"

This is a phase 3, randomised, multicentre, double-blind, placebo-controlled trial investigating the use of short term androgen deprivation therapy in the form of apalutamide (Erleada) in men on active surveillance for prostate cancer.

Confirming safety of combining UroLift System prior to SAbR for patients with newly diagnosed prostate cancer and a history of BPH, by measuring the acute complication rate of UroLift System implant in patients with BPH undergoing SAbR (within 90 days of treatment completion)

This is a prospective, interventional pilot study to evaluate the feasibility of randomizing patients diagnosed with prostate cancer to different treatment schemes according to their risk. Patients with a diagnosis of prostate adenocarcinoma (confirmed by biopsy), without signs of metastasis outside the pelvis in the staging study and without prior radiotherapy (RT) to the pelvic region will be recruited. The definition of risk group from the international guide National Comprehensive Cancer Network will be used. Low risk Favorable intermediate risk Unfavorable intermediate risk High risk The use of hormonal blocking will be at the discretion of each treating physician. The radiotherapy simulation will be carried out according to the institutional protocol for the treatment of prostate cancer. According to the risk group of the patients, the following randomization will be carried out: Low / intermediate favorable risk: Patients will be randomized to receive SBRT to prostate 36.25 Gy in 5 fractions, alternate days or weekly, with VMAT (technique and 6 Mega-voltage (MV) X-rays vs to SBRT to prostate 26 Gy in 2 fractions, 1 weekly fraction, with VMAT technique and 6 Mv X-rays. The volumes to be treated, ¨Clinical target volume¨ (CTV) will be defined as the prostate, according to the consensus of the Radiation Therapy Oncology Group (RTOG). Intermediate unfavorable risk and high risk: Patients will be randomized to receive SBRT to the prostate and seminal vesicles, 36.25 Gy in 5 fractions, alternate days or weekly, with VMAT technique and 6 MV X-rays vs SBRT to pelvis scheme of 25 Gy in 5 fractions with simultaneous integrated boost up to 36.25 to the prostate and seminal vesicles, with the same technique. Patients with positive pelvic node: Will be randomized to moderate hypofractionated RT , completing a dose of 44 Gy in 20 fractions to the pelvis with a simultaneous integrated boost up to 54-60 Gy in 20 fractions to metastatic lymphadenopathy and prostate with seminal vesicles, completing 60 Gy to prostate and seminal vesicles or to ultra hypofractionated RT to the prostate and macroscopic lymphadenopathy to 35 and 30-35 Gy respectively and 25 Gy in 5 fractions to the elective nodal areas.

Participants will either receive treatment with standard SBRT and the study drug Radium (Ra-223) dichloride, or standard SBRT alone.

OVM-200 will be tested in humans for the first time in Study OVM-200-100. Up to 52 patients aged 18-75 with prostate, lung or ovarian cancer will be enrolled in the Study to find out if OVM-200 is safe to continue studying it in patients with cancer. The Study consists of 2 parts: a dose escalation part and a dose expansion part. In the dose escalation part, up to 4 increasing doses of OVM-200 will be evaluated in small groups of cancer patients to find the recommended dose for the expansion part. The recommended dose of OVM-200 will then be given to cancer patients in the dose expansion part to confirm safety and understand how effective it is against their disease and if there are any side effects. Patients who agree to participate in the Study and pass screening will receive 3 doses of OVM-200 in total at 2-week intervals as an injection under the skin. After completing treatment with OVM-200 patients will be followed up for side effects and to monitor changes in their cancer. Patients will stay on the Study for about 6 months in total during which they will have 10 hospital visits. The Study will run at around 5 sites in the UK.

The PROQURE project aims to provide prostate cancer patients with more cure and better quality of life. The first part of this project (PROQURE-1) aims to explore an innovative combined modality treatment strategy for patients with node-positive prostate cancer (N1M0). The current standard of care for these patients, external beam radiotherapy (EBRT) of the prostate and regional pelvic nodes combined with 2-3 years androgen deprivation therapy (ADT), leads to suboptimal tumor control while inducing significant and potentially persistent toxicity. To overcome this, the current locoregional treatment is complemented with systemic Lutetium-177-PSMA radioligand therapy in a phase I study, with the aim to achieve better tumor control while potentially reducing or obviating ADT and its associated toxicity for future patients.

Researchers are seeking better ways to treat men who have non-metastatic castration resistant prostate cancer (nmCRPC). This type of prostate cancer-nmCRPC- is one that has not spread to other parts of the body yet keeps progressing despite low levels of (the hormone) testosterone. Signs of cancer progression are detected by higher (blood) levels of a protein known as "prostate-specific antigen" (PSA). PSA is made by both normal and cancerous cells in the body. An established treatment that is used to lower the amount of androgen hormones (e.g., testosterone) in the body is known as "Androgen deprivation therapy" (ADT), and all study participants will receive this (if they have not had surgery to remove their testicles). All participants will also receive the study-drug, darolutamide, which is already available for doctors to prescribe to patients with this condition. Darolutamide works by blocking the attachment of androgen hormones to androgen receptors in cancer cells, thereby blocking cancer progression and growth. There has been a previous research study that showed that patients with nmCRPC benefit from the combination of darolutamide plus Androgen deprivation therapy (ADT) when compared with placebo plus ADT therapy. Participants from mainland China were not included in the previous study. The present study focuses specifically on Chinese participants with nmCRPC, who will receive both medications- darolutamide plus ADT. Researchers will be using a "marker" of cancer- PSA- to look at how the PSA declines when participants take study treatment. By using the tumor marker PSA, researchers can more quickly identify how study participants are responding to their study treatment. All the participants will also take ADT. During the study, participants will take darolutamide until: (1) their cancer spreads (2) they start another type of cancer treatment (3) they have an adverse event that requires stopping the medication. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events is related to the study treatments. Other reasons for study discontinuation include: (4) a participant takes another type of medication that is not permitted to be taken during this study (5) the patient chooses to leave the trial or (6) the participant dies. Study participants will visit the study site every 12 weeks for the first 3 visits and after visit 3, visit interval will be every 16 weeks during treatment and after stopping treatment (participants may continue to be followed even after stopping treatment). It is anticipated that the whole study will last about 35 months. During the study, doctors will: (1) check the participants' overall health and heart health (2) take blood samples (3) take pictures of the participants' tumors and bones using CT, MRI, and bone scans and (4) ask the participants questions about how they are feeling, what medications they are taking, and about adverse events they might be having.

The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.

The goal of this clinical trial is to compare two dose schedules of stereotactic radiation therapy in patients with localized prostate cancer. Historically, external beam radiation to treat localized prostate cancer was given in small treatments over a period of multiple weeks. Recent studies have shown that with newer technologies and better understanding of how prostate cancer responds to radiation, the same effective dose can be given in as few as 5 treatments. This study is comparing this newer standard course of 5 treatments with an even shorter course of just 2 treatments. The dose for the 2 treatments is based on a form of internal radiation called brachytherapy, but in this study, that dose will be given using external radiation, without the need for invasive procedures. In order to make sure that the radiation therapy is given in a way that minimizes the risk of side effects to the surrounding organs, including the rectum and bladder, prior to radiation a hydrogel material will be inserted behind the prostate in order to distance the rectum further from the prostate gland, and small gold markers will be inserted into the prostate to decrease any possible movement during treatment. The main questions are whether 2-treatment radiation is tolerated as well and is as effective at treating prostate cancer, compared to the standard 5-treatment course of radiation.

Various approaches are currently being developed for prostate cancer immunotherapy. However, a major challenge facing the development of cancer immunotherapy is the identification of tumors that would best respond to this type of treatment. Different studies suggest that prostate cancer more likely to progress are more infiltrated by exhausted T cells expressing the cell surface protein PD1 (Programmed cell death 1). Therefore, there is a strong rationale for selecting patients at higher risk of progression for testing the efficacy of anti-PD1 therapy. High glucose metabolism as detected by fludeoxyglucose F18 (FDG)-positron emission tomography (PET) (18FDG-PET) imagery is an innovative biological biomarker-based method to identify patients at higher risk of recurrence and early failure to hormonotherapy. Recent study demonstrated that high intra-prostatic 18-FDG-uptake was associated with higher Gleason grades. Therefore the one third of Gleason ≥ 8 prostate cancer patients with higher 18FDG uptake would be ideal candidates for early immunotherapy treatments based on anti-PD-1 such as pembrolizumab. The study aimed to identify biomarkers predictive the response to Pembrolizumab given prior to radical prostatectomy in participants with primary prostate cancer at high risk of progression.