|Protocol||Trial Name and Objective|
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.
Secondary endpoints: (1) PSA response rate (Percentage of patients with an undetectable PSA at 8 months from PSA0). (2) Effects of each arm on overall quality of life, with particular attention to libido, potency, anxiety, depression, hot flashes and fatigue. (3) Frequency and intensity of non-hematologic adverse events. (4) Testosterone and leuteinizing hormone (LH) recovery rates.
Tertiary endpoint: Correlative tissue analysis with clinical outcomes while on study treatment.
A Phase II Trial of the Aurora Kinase A Inhibitor MLN8237 in Patients with Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer
Primary Objective: to evaluate the objective response rate of MLN8237 for patients with neuroendocrine prostate cancer.
Secondary Objective: to determine the overall survival, progression free survival, PSA response rate, circluting tumor cell (CTC) response, and serum neuroendocrine markers in response to therapy.
Exploratory objectives: to evaluate molecular biomarker archival and metastatic tissue, including IHC and FISH for Aurora kinase A and N-myc overexpression and amplification, meuroendocrine markers, AR status, ERG fusion, and other genomic mutations determined by sequencing. To evaluate plasma DNA for AURKA and MYCN amplification.
A first-in-human phase I single-agent open-label dose-escalation study of every three-week dosing of oral ONC201 in patients with advanced solid tumors
To determine the recommended maximal tolerated dose (MTD) or recommended phase II dose of single agent ONC201 orally once every three weeks
To characterize the safety and tolerability of ONC201 in patients with tumors that have a high frequency of PI3 kinase pathway or RAS signaling activation (metastatic castrate resistant prostate cancer, metastatic renal cell carcinoma, melanoma, glioblastoma multiforme, breast cancer).
Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed with Metastatic Prostate Cancer
To determine the safety and feasibility of cytoreductive prostatectomy in men with newly diagnosed clinical TxN1Mx or TxNxM1 prostate cancer (herein, collectively referred to as metastatic prostate cancer).
Time to PSA nadir and castration resistance following cytoreductive prostatectomy and
subsequent standard systemic therapy, androgen deprivation.
Salvage Therapeutic Radiation with Enzalutamide and ADT in Men with Recurrent Prostate Cancer (STREAM)
Primary Objective: to describe the 2 year progression-free survival in men with recurrent PSA-only disease after prostatectomy receiving combined enzalutamide and standard androgen-deprivation therapy with salvage radiation therapy and who have had testosterone recovery to greater than 100 at 24 months.
Secondary Objectives: (1) to determine the proportion of men at 1, 2 and 3 years with a PSA of less than 0.1 ng/mL and testosterone receovery to greater than 100. (2) to describe the 3 year progression-free suvival in men receiving combined enzalutamide and standard androgen-deprivation therapy with salvage radiation therapy and who have had testosterone recovery to greater than 100. (3) to describe the biochemical (PSA) progression free survival over time. (4) to describe the PSA nadir. (5) to describe the time to testosterone recovery. (6) to describe the safety profile of combination enzalutamide, ADT, and XRT.
A Phase 2 Randomized Discontinuation Trial in Patients with Hormone-Dependent Rising Prostate-Specific Antigen Progression After Local Therapy For Prostate Cancer Evaluating the Synergy of Metformin Plus Aspirin (PRIMA Trial)
1.1 Primary Endpoints
1.1.1 To determine the effect of metformin and aspirin on the change in PSA progression in men with rising PSA after definitive therapy for localized prostate cancer and stable disease during a run-in period with the study regimen.
1.2 Secondary Endpoints
1.2.1 To determine the feasibility and safety of administering metformin and aspirin
1.2.2 To determine the effect of metformin and aspirin on PSA levels and the serum obesity-related PCa biomarkers (insulin, IGF-1, IL-1â, IL-6, and TNF-á)
A randomized, double blind, multicenter, parallel-group, phase III study to evaluate efficacy and safety of DCVAC/PCa versus placebo in men with metastatic castration resistant prostate cancer eligible for 1st line chemotherapy
The primary objective is to show superiority of treatment with DCVAC/PCa in addition to Standard of Care Chemotherapy over placebo in addition to Standard of Care Chemotherapy in men with mCRPC as measured by OS.
The secondary objectives include assessments of safety, time to tumour progression, time to prostate-specific antigen progression, progression free survival, occurrence of skeletal related events (SRE), proportion of patients requiring second line treatment introduction
ARN-509-003: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer (SPARTAN)
To demonstrate superiority in the metastasis-free survival (MFS) of men with high risk Non metastatic -CRPC treated with ARN-509 versus placebo
Main secondary objective
To demonstrate superiority in the metastasis-free survival (MFS) of men with high risk NM-CRPC treated with ARN-509 versus placebo
NCI/CTEP #9068: A Phase II Multicenter Study of AMG 386 and Abiraterone in Metastatic Castration Resistant Prostate Cancer
Primary Objective: To estimate the treatment effect as measured by progression free survival (PFS) in patients treated with AMG 386 plus abiraterone/prednisone relative to abiraterone/prednisone alone.
Secondary Objectives: (1) to evaluate the overall survival of the enrolled patients and the safety and toxicity profile of the combination; (2) to assess changes in genetic biomarkers related to androgen and angiogenesis signaling axis and to correlate that with efficacy; (3) to assess changes in the molecular markers of angiogenesis and circulating tumor cells before (CTCs) and after administration of the combination; (4) to determine whether there are changes in AR signaling status in CTCs before and after treatment; (5) to determine radiographic progression free survival (rPFS)
A Randomized Phase II Study Comparing Bipolar Androgen Therapy vs. Enzalutamide in Asymptomatic Men with Castration Resistant Metastatic Prostate Cancer: The TRANSFORMER Trial
Primary Objective: To determine if treatment with supraphysiologic testosterone (T) will improve radiographic progression free survival compared to enzalutamide in asymptomatic men with evidence of progressive metastatic CRPC post-treatment with abiraterone.
Secondary Objectives: (1) Further investigate the safety of cyclical parenteral testosterone in asymptomatic men with recurrent castrate resistant prostate cancer. (2) PSA response rate. (3) Objective response rate in patients with measurable disease on CT scan using RECIST criteria. (4) Time to PSA progression to each arm of therapy based on PCWG2 criteria. (5) PSA response rate to enzalutamide post-BAT. (6) PSA response rate to BAT post-enzalutamide. (7) Comparison of effect of each treatment arm on quality of life as assessed by patient completion of validated instruments.
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.
Intimacy-Enhancing Couples' Intervention for Localized Prostate Cancer
The proposed study has two primary aims.
Aim 1: To evaluate the impact of an Intimacy-Enhancing Couples' intervention (IEC) versus a General Health and Wellness Intervention (GHW) and a Usual care control (UC) on patient and partner psychological and relationship outcomes.
Aim 1a.: To determine whether relationship length, pre-intervention relationship satisfaction, and men's pre-intervention masculinity moderate the effects of IEC on couples' psychological and relationship outcomes.
Aim 2: To evaluate whether IEC has an effect on couples' communication and intimacy when compared with GHW and UC and to determine whether changes in relationship communication and intimacy mediate changes in couples' psychological and relationship outcomes.