Prostate Cancer PSMAddition

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)

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 mHSPC. In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy.

Key Inclusion Criteria:

• Participants must have an ECOG performance status of 0 to 2
• Participants must have histological pathological, and/or cytological confirmation of adenocarcinoma of the prostate
• Participants must have adequate organ function:
  • Bone marrow reserve: ANC ≥ 1.5 x 109/L, Platelets ≥100 x 109/L, Hemoglobin ≥ 9 g/dL.
  • Hepatic: Total bilirubin < 2 x the institutional upper limit of normal (ULN). For participants with known Gilbert’s Syndrome ≤ 3 x ULN is permitted, ALT or AST ≤ 3.0 x ULN OR ≤ 5.0 x ULN for participants with liver metastases
  • Renal: eGFR≥ 50 mL/min/1.73m2using the Modification of Diet in Renal Disease (MDRD) equation, Albumin≥ 2.5 g/dL
• HIV-infected patients who are healthy and have a low risk of acquired immune deficiency syndrome (AIDS)-related outcomes can participate in this trial
• Patients must have at least one metastatic bone and/or soft tissue/visceral lesion documented in one of the following manners within 28 days prior randomization:
  • Metastatic disease to the bone(in any distribution) visible on 99Tc-MDP bone scintigraphy on either pre-ADT scans or baseline scans.
  • Lymph node metastases of any size or distribution.
  • Visceral metastases of any size or distribution. 
• Treatment naïve OR minimally treated with:
  • Prior LHRH agonist/antagonist used in the adjuvant/neo-adjuvant setting must have been discontinued > 12 months prior to ICF signature AND must not have exceeded 24 months of therapy AND must not have shown disease progression within 12 months of completing adjuvant/neo-adjuvant therapy.
  • Up to 45 days of luteinizing hormone-releasing hormone(LHRH) agonist/antagonists or bilateral orchiectomy with or without first generation anti-androgen (e.g. bicalutamide, flutamide) for metastatic prostate cancer is allowed prior to ICF signature. If given, first generation anti-androgen must be discontinued prior to start of therapy.
  • Up to 45 days of CYP17 inhibitor or ARDT exposure for metastatic prostate cancer is allowed prior to ICF signature. No exposure for earlier stages of prostate cancer is allowed

Primary Study Contact: Sierra Irizarry 860-972-4062

Research procedures may be conducted at the following locations: Hartford Hospital

Non-interventional study visits may take place at the following locations: HHC Medical Group at Manchester, Hospital of Central Connecticut, Midstate Medical Center