An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer...
Prostatic NeoplasmsThe purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.
Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate...
Metastatic Prostate CarcinomaRecurrent Prostate Carcinoma1 moreThis phase II trial studies the side effects and how well abiraterone acetate, niclosamide, and prednisone work in treating patients with hormone-resistant prostate cancer. Androgens can cause the growth of prostate cells. Hormone therapy using abiraterone acetate may fight prostate cancer by lowering the amount of androgen the body makes. Niclosamide is a drug that may block another signal that can cause prostate cancer cell growth. Prednisone is a drug that can help lessen inflammation. Giving abiraterone acetate, niclosamide, and prednisone may be a better treatment for patients with hormone-resistant prostate cancer.
Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate...
Prostate CancerA prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.
Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer...
Prostate CancerThe purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer. CAN-2409 involves the use of aglatimagene besadenovec to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. CAN-2409 has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that CAN-2409 can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the CAN-2409 or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.
Enzalutamide With and Without Ribociclib for Metastatic, Castrate-Resistant, Chemotherapy-Naive...
Hormone-Resistant Prostate CancerMetastatic Prostate Carcinoma2 moreThis partially randomized phase IB/II trial studies the side effects and best dose of ribociclib when given with enzalutamide and to see how well they work compared to enzalutamide alone in treating patients with prostate cancer that does not respond to treatment with hormones (hormone resistant), has spread from the primary site (place where it started) to other places in the body (metastatic), is chemotherapy naïve, and retains retinoblastoma expression. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether enzalutamide works better when given with or without ribociclib in treating patients with prostate cancer.
Pilot Study of Whole Gland Salvage HDR Prostate Brachytherapy for Locally Recurrent Prostate Cancer...
Prostate Cancer RecurrentRadiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% of patients who recur, there is no consensus on the optimal salvage therapy. Salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease (cryotherapy), and high frequency ultrasound to treat the disease. There are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. The aim of this pilot study is to look at the feasibility and toxicities of whole gland salvage treatment of the prostate using temporary implantation of radioactive seeds into the prostate.
Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate...
Castration-Resistant Prostate CarcinomaMetastatic Prostate Carcinoma2 moreThis phase I/II trial studies the side effects and best dose of cabazitaxel when given together with enzalutamide in treating patients with prostate cancer that has spread to other places in the body (metastatic) and has not responded to treatment with hormones or no longer responds to treatment with hormones (hormone-resistant). Drugs used in chemotherapy, such as cabazitaxel, 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. Androgen can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of androgen by the tumor cells. Giving cabazitaxel together with enzalutamide may work better in treating metastatic, hormone-resistant prostate cancer.
Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer
Newly Diagnosed Oligometastatic Prostate CancerThis is a trial for patients with newly diagnosed metastatic prostate cancer with 5 or fewer sites of metastases. The trial involves surgery (removal of the prostate) or radiation to the prostate, six months of hormone therapy, and stereotactic body radiotherapy to the sites of metastasis.
Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory...
Relapsed/Refractory Multiple Myeloma (RRMM)Metastatic Colorectal Cancer (mCRC)4 moreThis is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in participants with relapsed/refractory multiple myeloma (MM), metastatic colorectal cancer (mCRC), metastatic castration resistant prostate cancer (mCRPC), higher risk myelodysplastic syndrome (HRMDS), acute myeloid leukemia (AML) and newly diagnosed intermediate/high-risk MDS. Dose escalation and dose expansion may be included for all parts of the study as determined by ongoing study results.
Androgen Suppression With Stereotactic Body or External Beam Radiation Therapy (ASSERT)
Prostate CancerTwo radiation therapy techniques are commonly used for the treatment of intermediate and high risk prostate cancer: brachytherapy and external beam radiation therapy (EBRT). However, both have limitations. Brachytherapy, in which radioactive seeds are inserted into the prostate, produces excellent outcomes but is invasive and not all patients are eligible or willing to receive this treatment. EBRT, while gentle at the time of delivery, tends to be very prolonged and may have poorer outcomes than brachytherapy. This study will examine the use of stereotactic ablative radiotherapy (SABR), in which patients are given only a few, high dose radiation treatments. Treatments are short, non-invasive, applicable to patients not able to do brachytherapy, and may be more effective than conventional EBRT. This study will compare SABR with EBRT in terms of the rates of acute and late toxicities for each treatment, disease-free survival, and health-related quality of life measures.