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|Protocol||Trial Name and Objective|
Phase I/II Randomized Trial of LBH589 (Pabinostat) at Two Dose Levels Combined with Bicalutamide (Casodex) in Men with Castration-Resistant Prostate Cancer
The purpose of this study is to determine the safety (Phase 1) and efficacy, or effectiveness (Phase 2) of an investigational drug, LBH589, in combination with Casodex® for the treatment of prostate cancer. The purpose of the Phase 1 study is to determine the maximum tolerated dose of investigational drug LBH589 in combination with Casodex®. The purpose of the Phase 2 study is to determine the effectiveness of investigational drug LBH589 in combination with Casodex® at the maximum tolerated dose, compared to a lower dose of LBH589 in combination with Casodex®.
Stereotactic Hypofractionated Accelerated Radiation and Prostatectomy in Patients with Elevated Risk (The SHARPER Trial - A Phase One Study)
1. Purpose/Specific Objectives
Phase I/II Study of Safety and Efficacy of Muscadine Plus (MPX) in Men with Prostate Cancer: A Randomized, Double-Blind Placebo Controlled Study of the Effects of Two Doses of MPX Capsules on Rising Prostate-Specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer: Phase II
Phase II Primary Objective: To define the effects of placebo and two different daily doses of Muscadine Plus (MPX) on prostate specific antigen doubling time (PSADT) in men who have rising PSA after initial definitive therapy for localized prostate cancer.
NCI/CTEP 9012: A Randomized Gene Fusion Stratified Phase 2 Trial of Abiraterone with or without ABT-888 for Patients with Metastatic Castration-Resistant Prostate Cancer
Primary Objectives: (1) To evaluate the role of ETS gene fusion as a predictive biomarker for response to hormone therapy (abiraterone) alone or hormone therapy plus PARP-1 targeted therapy (ABT-888) in patients with metastatic castration resistant prostate cancer. (2) To evaluate whether the addition of PARP-1 targeted therapy is superior to hormone therapy alone based on ETS gene fusion status.
A Phase II Study of CTLA Blockade by Ipilimumab plus Androgen Suppression Therapy in Patients with an Incomplete Response to AST Alone for Metastatic Prostate Cancer
Primary endpoint: the proportion of patients who achieve an undetectable PSA (less than 0.2 ng/ml) after initiation of ipilimumab therapy.
A phase II study of ABT-263/Abiraterone (Arm A) or ABT-263/Abiraterone and Hydroxychloroquine (Arm B) in Patients with Metastatic Castrate Refractory Prostate Cancer (CRPC) and Progression following Abiraterone
ABT-263 with or without hydroxychloroquine will target mechanisms
A Phase II, Randomized, Three-Arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients with Prostate Cancer with a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy
The primary endpoint for each cohort is progression-free survival (PFS) at 18 months from the start of randomization (PSA0). PFS is defined as an undetectable (less than or equal to 0.05 ng/mL) PSA with a non-castrate level of testosterone (greater than 150 ng/dL). Pathological lymph nodes (whether target or non-target) must also have reduction in short axis to less than 10mm (Compelte Response per RECIST) in order to meet the criteria for PFS.
A Pilot Study To Assess Feasbility Of Collection Of Prostate Cancer Cells In Peripheral Blood Using A Biotinylated Inhibitor (Biotin-Peg12-Ctt-54) Of The Enzyme-Biomarker PSMA And Culturing The Captured Prostate Cancer Cells In A Zebrafish Xenograft
1. To determine the feasibility of capturing prostate cancer cells obtained from specimens of patient derived peripheral blood using a novel Biotin-PEG12-CTT-54 based capture technique
NCI/CTEP #7354: A randomized Phase II trial combining vaccine therapy with PROSTVAC /TRICOM and Flutamide, vs Flutamide alone in men with androgen insensitive, non metastatic (D0.5) prostate cancer
* To determine if use of a combination of vaccine plus flutamide may be associated with a trend toward improvement in time to treatment failure compared to flutamide alone.
NCI/CTEP #8983: A Phase I Trial of MK-2206 and Hydroxychloroquine in Solid Tumors, Melanoma, Renal and Prostate Cancer to Examine the Role of Autophagy in Tumorigenesis
Primary - to define the maximum tolerated dose (MTD) of MK-2206 and hydroxychloroquine (HCQ) when used in combination.
Assessment of the Biological Effect of Autophagic Inhibition with Hydroxychloroquine in Prostate Cancer
Primary - (1) to determine the effect of hydroxychloroquine on markers of autophagy in prostate tumor.
A Phase 3, Randomized, Double-Blind, Controlled Trial of Cabozantinib (XL184) vs. Mitoxantrone Plus Prednisone in Men with Previously Treated Symptomatic Castration-Resistant Prostate Cancer
The objectives of the study are to evaluate the safety and efficacy of cabozantinib compared with mitoxantrone plus prednisone. Efficacy will be measured by (1) proportion of subjects with pain response at week 6 confirmed at week 12. (2) Bone scan response at week 12 per IRF (primary analysis designates subjects with soft tissue progression as non-responders). (3) Overall survival
ECOG E2810: Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy
1 .To evaluate disease-free survival with pazopanib as compared to placebo, defined as the time from randomization to the development of recurrent disease, second primary cancer (other than localized breast, localized prostate, or non-melanoma skin cancer) or death from any cause for patients with metastatic RCC with no evidence of disease following metastatectomy.
SWOG S1216: A Phase III Randomized Trial Comparing Androgen Deprivation Therapy +TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostrate Cancer
Primary: overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide
Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
The proposed study has two primary aims.
Randomized Controlled Trial (RCT) of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors. A Study of The Cancer Institute of New Jersey Oncology Group (CINJOG)
We propose to develop and evaluate a comprehensive and innovative multimedia program designed to facilitate the post-treatment transition into survivorship. The design of the proposed intervention, the Virtual Survivorship Resource Center for Prostate Cancer (VSRC-PC), will be theoretically based on the team's Cognitive-Social Health Information Processing Model. The VSRC-PC will focus on promoting adaptive coping within four key post-treatment domains: 1) Physical Dysfunction (e.g., physical symptoms); 2) Emotional Well- Being (e.g., fear of recurrence); 3) Interpersonal Concerns (e.g., sexual intimacy issues); and 4) Practical Barriers (e.g., medical follow-up challenges). The proposed research will be the first RCT to evaluate not only a comprehensive but also highly disseminable and self-sustaining intervention for facilitating post-treatment adaptation among early-stage Pca survivors. The proposed research will be the first RCT to evaluate not only a comprehensive but also highly disseminable and self-sustaining intervention for facilitating post-treatment adaptation among early-stage Pca survivors.