Colli-Pee

Prospective Collection of Urine Samples
from Men Undergoing Prostate Biopsy


APA RP

Study Type:

Interventional (Clinical Trial)

Study Design:

  • Estimated Enrollment: 94 participants
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Official Title: A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases


PREVALENCE

Study Type:

Observational

Study Design:

  • Estimated Enrollment: 10000 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective

Official Title: Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer


LAEKNA

Study Type:

Interventional (Clinical Trial)

Study Design:

  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Allocation: Randomized
  • Intervention Model: Sequential Assignment
  • Intervention Model Description: Phase 1 Dose Escalation to determine Recommended Phase II Dose (RP2D) of LAE001/Prednisone plus Afuresertib in m-CRPC patients. Once RP2D is determined, Phase II will evaluate LAE001/Prednisone plus Afuresertib vs Afuresertib monotherapy in m-CRPC patients.
  • Estimated Enrollment: 74 participants
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Official Title: A Phase I/II Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib in Patients With Metastatic Castration-resistant Prostate Cancer Following Standard of Care Treatment


DAROL

Study Type:

Observational

Study Design:

  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Estimated Enrollment: 1000 participants

Official Title:Darolutamide Observational Study in Non-metastatic Castration-resistant


ESCALATE

Study Type:

Interventional[Clinical Trial]

Study Design:

    Interventional Model: Sequential Assignment

  • Intervention Model Description: Lead-in open-label androgen-receptor blocker (ARB) followed by double-blind Radium-223 or placebo.
  • Estimated Enrollment: 499 participants
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • Official Title:

    ESCALATE, A Phase III Randomized Study Comparing Enzalutamide or Darolutamide With Radium-223 vs Enzalutamide or Darolutamide With Placebo and the Effect Upon Symptomatic Skeletal Event-Free Survival for mCRPC Patients


SAFELY

Study Type:

Observational [Patient Registry]

Study Design:

  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Estimated Enrollment: 600 participants
  • Target Follow-Up Duration: 10 Years
  • Official Title:

    A Multi-center, Prospective Active Surveillance Registry Trial Assessing the Performance of a Non-invasive Immunogenomic Blood Test for Indolent Prostate Cancer Disease Management.


Ulysses

Study Type:

Interventional

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose: Treatment

Official Title:

A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer


EMBARK

Study Type:

Interventional

Study Design:

  • Actual Enrollment: 1068 participants
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Official Title: A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy)


Atlas

Study Type:

Interventional

Study Design:

  • Allocation: Randomized
  • Actual Enrollment: 1503 Participants
  • Intervention Model: Parallel Assignment
  • Masking: Double Blind (Subject, Investigator)
  • Primary Purpose: Treatment

Official Title:

ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy.