MRI-guided Transurethral Urethral Ultrasound Ablation for the Treatment of Intermediate Grade Prostate...
Prostate CarcinomaStage I Prostate Cancer AJCC v81 moreThis clinical trial tests whether the magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) procedure is safe and effective in treating patients with intermediate grade prostate cancer. TULSA ablation is a minimally invasive procedure that uses targeted ultrasound device to deliver high-frequency, electric current to kill cancer cells by heating them. The TULSA procedure may help patients avoid surgery and help improve prostate cancer patients' quality of life.
Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable...
Prostate CancerBRCA1 Mutation3 morePhase 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.
A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors
Advanced Solid TumorCastration-Resistant Prostatic Cancer5 moreStudy CP-MGC018-02 is a study of vobramitamab duocarmazine (MGC018) in combination with lorigerlimab. The study is designed to characterize safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics, and preliminary antitumor activity. Participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors including, but not limited to, mCRPC, melanoma, pancreatic cancer, hepatocellular carcinoma (HCC), ovarian cancer, and renal cell carcinoma (RCC) will be enrolled. Vobramitamab duocarmazine and lorigerlimab are administered separately on Day 1 of every 4-week (28-day) cycle at the assigned dose for each cohort. Participants who do not meet criteria for study drug discontinuation may receive study drugs for up to 2 years. Tumor assessments are performed every 8 weeks for the initial 6 months on study drugs, then every 12 weeks (± 21 days) until progressive disease (PD). Participants will be followed for safety throughout the study. .
Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer
Prostate CancerIt is currently unclear if immediate curative treatment (radiotherapy or surgery) of high-risk prostate cancer without metastasis in older men (>=75 years) generates the same survival benefits as in younger patients or if the harms/ side-effects of immediate curative treatment outweigh the benefits. In this study the investigators randomize older patients with high-risk, non-metastatic high-risk prostate cancer to either immediate curative therapy or to conservative, more problem-oriented therapy to investigate if immediate curative treatment prolongs life, improves quality of life and is cost-effective.
Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration...
Prostate CancerThis study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival of study participants, when overall survival is defined as the time from randomization until the date of death due to any cause.
A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions...
Non-metastatic Castration-resistant Prostate CancerResearchers are looking for a better way to treat men who have non-metastatic castration-resistant prostate cancer (nmCRPC). This is a type of cancer of the prostate that has not yet spread to other parts of the body and that keeps progressing even when the amount of male sex hormones like testosterone (also called androgens) is reduced to very low levels. To reduce androgen levels in prostate cancer patients, androgen deprivation therapy (ADT) is often used. As androgens stimulate the growth of prostate cancer cells, low levels are needed to reduce or slow the growth of these tumors. In men with nmCRPC, the cancer worsens despite low testosterone levels (also called castration resistant). Prostate-specific antigen (PSA) is a protein that is made by both normal cells and by cancerous cells in the body. Thus, PSA levels can be taken as a marker for prostate cancer development. Men with nmCRPC usually have higher levels of (PSA) than normal. They are considered "high risk" if they show signs of quickly increasing PSA levels as this could mean that the tumor is growing and might spread to other parts of the body. The study treatment darolutamide is already available in certain countries for doctors to prescribe to men with prostate cancer that has not yet spread to other parts of the body. It works by blocking androgens from attaching to proteins in cancer cells in the prostate. Results of a previous study in men with high-risk nmCRPC who received darolutamide in addition to ADT are already available, but this study had no Indian patients and was not conducted in India. Therefore, the main purpose of this study is to learn how safe darolutamide is when taken in addition to ADT in Indian participants with high-risk nmCRPC. To answer this question, the researchers will collect all medical problems the participants have that arise during the study and that may or may not be related to the study treatment. These medical problems are also known as "adverse events" (AE). The following information regarding safety of darolutamide will be collected during the study: the number and severity of AEs that are non-serious or serious the number of participants who have to permanently stop the treatment due to AEs the number of participants who have to change the amount of study drug taken due to AEs AEs can be: abnormal results of laboratory tests, physical examinations, or heart health examinations using ECG (detects heart problems by measuring the electrical activity generated by the heart as it contracts). relevant changes in vital signs relevant changes of the participant's daily living abilities (ECOG performance status) These results will then be compared with the results from the previous study to identify any differences for this group of participants. In addition, researchers will collect and compare data on how well darolutamide worked under real world conditions in this group of participants. All participants will take darolutamide as tablets by mouth twice a day. The participants will visit the study center at the start of the study, and then every 16 weeks until their cancer gets worse, they develop medical problems, they leave the study or until the study is terminated. During the study, the study team will take blood and urine samples do physical examinations check vital signs examine heart health using ECG assess the participant's ECOG performance status ask the participants questions about how they are feeling and what AEs they are having. If the trial is stopped, participants may have the option to continue to receive darolutamide, provided they benefit from the treatment.
Protons vs. Photons for High-risk Prostate Cancer
Prostate CancerRadiotherapy Side EffectThe purpose of this study is to assess late gastro-intestinal side-effects comparing proton therapy to photon therapy in high-risk prostate cancer patients receiving whole pelvic irradiation.
Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)...
Prostate CancerThis is a single-site trial for 42 subjects with intermediate risk prostate cancer who undergo Irreversible Electroporation (IRE) followed by Magnetic Resonance guided Radiotherapy MRgRT. The investigators hypothesize that the combined therapy will feasible and be safe to perform with low morbidity. Ultimately, RTIRE may provide optimal treatment for intermediate risk prostate cancer patients.
A Study to Assess BMS-986460 in Participants With Metastatic Castration-resistant Prostate Cancer...
Metastatic Castration-resistant Prostate CancerThe purpose of this study is to assess the safety, tolerability, and preliminary efficacy of BMS-986460 in men with Metastatic Castration-resistant Prostate Cancer.
TERPS Trial for de Novo Oligometastic Prostate Cancer
Prostate CancerOligometastatic DiseaseThis research is being done to determine if we can improve the outcome of prostate cancer patients who have failed primary treatment - surgery or local radiation to the prostate - and have three or fewer bone or soft tissue metastases.