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A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC).

OBJECTIVE AND HYPOTHESISPrimary ObjectiveThe primary objective is to determine whether abiraterone acetate in combination with low-doseprednisone and androgen deprivation therapy (ADT) is superior to ADT alone in improving rPFS and OS insubjects…

A Phase 3 study to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in subjects with castrate-resistant prostate cancer.

Am2: Primary Objective* To compare the Overall Survival (OS) benefit of docetaxel and prednisone with and without lenalidomide as first-line combination therapy in chemo-naïve metastatic CRPC Secondary Objectives* Progression-Free Survival (PFS), *…

Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs
Placebo in Asymptomatic or Minimally Symptomatic Patients with Metastatic
Chemotherapy-Naïve Castration Resistant Prostate Cancer

The objective of this study is to compare the overall survival of patients with prostate cancer who are no longer responding to hormone therapy (castration resistant) and who have not yet received chemotherapy live longer (overall survival) when…

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK 700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy

Primary Objective:• To determine if orteronel plus prednisone improves overall survival (OS)Key Secondary Objectives: • To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS)• To determine if orteronel plus…

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer

To determine if orteronel plus prednisone improves radiographic progression-freesurvival (rPFS)To determine if orteronel plus prednisone improves overall survival (OS)

A prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate with the GreenLight XPS Laser System and Transurethral resection of the Prostate for Treatment of benign Prostatis Hyperplasia

The study will compare procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP). The study requires use of the CE marked GreenLight XPS* Laser System (GreenLight…

A Randomized, Open Label, Phase III, Multicenter, 2-Arm Study of Androgen deprivation +/- Taxoterere* (Docetaxel) for Non metastatic Prostate Cancer Patients with a Rising PSA.

To evaluate and compare progression free survival (PSA) between the two treatment arms.

Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis

To provide access to Radium-223 dichloride to patients diagnosed with CRPC/HRPC with bonemetastasis.

A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with Custirsen (OGX-011) in Men with Metastatic Castrate Resistant Prostate Cancer

To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm.

An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy

Primary Objective - To evaluate the time to PSA >4 ng/mL during the first cycle of IAD after the end of an induction period with degarelix (7 monthly treatments) in prostate cancer patientsSecondary Objectives - To evaluate the time to PSA .4…

A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs. Prednisone in Metastatic Castration-resistant Prostate Cancer Patients who have Received Prior Docetaxel and Prior Abiraterone or MDV3100

The objective of this study is to evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease…

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate-Resistant Prostate Cancer.

The primary objective of this study is:To confirm the effect of Tasquinimod on delaying disease progression or death compared with placebo.The secondary objectives of this study are:• To determine the effect of Tasquinimod on overall survival, time…

VISION: An international, prospective, open label, multicenter, randomized Phase 3 study of 177LU-PSMA-617 in the treatment of patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)

The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/…

A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Abiraterone Versus Placebo + Abiraterone as Treatment for Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Characterised by PTEN deficiency (CAPItello-281)

This study has been transitioned to CTIS with ID 2023-504998-20-00 check the CTIS register for the current data. - To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of radiographic progression-free…

A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve subjects with bone predominant metastatic castration-resistant prostate cancer (CRPC)

to provide access to Radium-223 dichloride together with abiraterone and prednisone to patients diagnosed with CRPC with bonemetasasis.

Effectiveness of focal therapy in men with prostate cancer (ENFORCE)

We hypothesize that a significant proportion of the patients will benefit more from focal therapy as compared to usual care in terms of morbidity and quality of life, without compromising oncological effectiveness. Primary objective: To study the…

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

This study has been transitioned to CTIS with ID 2023-506365-64-00 check the CTIS register for the current data. The purpose of this study is to investigate if niraparib added to a standard treatment (consisting of abiraterone acetate plus…

PROCADE: A Multinational Phase 3, Randomized, Double-Blind, Non-Inferiority, Efficacy and Safety Study of Oral HC-1119 versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Primary Objective:• To determine the efficacy of HC-1119 as compared to enzalutamide as assessed by overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) until 24 weeks.Key Secondary Objective:• To…

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer

The purpose of this study is to understand if a new treatment for prostate cancer (niraparib) added to a standard treatment (abiraterone acetate plus prednisone) will work better than the standard treatment alone.Cohort 3: the purpose is to evaluate…

An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies

This study has been transitioned to CTIS with ID 2022-502084-38-00 check the CTIS register for the current data. Primary- Continuation of treatment- SafetySecondairy- Documentation of tolerability