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Ph III Comparing 177Lu-PSMA-617 in Combo w/ SOC vs SOC Alone, in Adult Male Pts w/ mHSPC

Arash Rezazadeh Kalebasty


A Study On:

  • Prostate

Status:

  • Open

Eligibility

Adult

Interested in joining this trial?

Official Title

PSMAddition: An International Prospective Open-Label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination with Standard of Care, Versus Standard of Care Alone, in Adult Male Patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Details

The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with metastatic hormone-sensitive prostate cancer (mHSPC). In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy. Approximately 1126 patients will be randomized in this study.


Eligibility

You can join if...

Inclusion Criteria:

  • Patients must have metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma (current or prior biopsy of the prostate and/or metastatic site)
  • Patients must have a life expectancy >9 months as determined by the study investigator

Exclusion Criteria:

  • Ongoing participation in any other clinical trial
  • Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. Participants with an active documented COVID-19 infection (any grade of disease severity) at time of informed consent may be included only when completely recovered (in accordance with local guidance).
  • History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study

Get in touch with our study team