The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)

Part of paid clinical trials in Orange, California.

Sponsor
Telix Pharmaceuticals (Innovations) Pty Limited
Study ID
NCT06520345
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 177Lu-TLX591 — DRUG
    Participants randomized to Group A will receive two 76 mCi (±10%) doses of 177Lu-TLX591 14 days apart
  • Enzalutamide — DRUG
    Enzalutamide (starting dose 160 mg daily)
  • Abiraterone — DRUG
    Abiraterone (starting dose 1,000 mg daily) + prednisone / prednisolone (up to 10 mg per day for the standard formulation)
  • Docetaxel — DRUG
    Docetaxel: Single agent chemotherapy will consist of docetaxel given at a recommended dose of 75mg/m2 IV every 3 weeks given in combination with oral prednisone / prednisolone 5mg twice a day (or equivalent) for up to 10 cycles

Study Details

The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment

Key Dates

Start date
Jul 26, 2024
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2030

Study Design

Enrollment
520 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 177Lu-TLX591 + Enzalutamide or Abiraterone or Docetaxel
    Lutetium (177Lu) rosopatamab tetraxetan (177Lu-TLX591) 76 mCi (±10%) given approximately 14 days apart, plus SOC. SOC is either: Concurrent enzalutamide (starting dose 160 mg daily) + prednisone / prednisolone (5 mg twice a day) or equivalent. or Concurrent abiraterone (starting dose 1,000 mg daily) + prednisone / prednisolone (5 mg once daily for the standard formulation), methylprednisolone (4 mg twice daily for the fine particle formulation) or dexamethasone (1 mg once daily) or Sequential Docetaxel: Single agent chemotherapy will consist of docetaxel given at a recommended dose of 75mg/m2 IV every 3 weeks given in combination with oral prednisone / prednisolone (5mg twice a day) or equivalent for up to 10 cycles.
  • Active Comparator: Control Arm (Enzalutamide or Abiraterone or Docetaxel)
    SOC is either: Enzalutamide (starting dose 160 mg daily). or Abiraterone (starting dose 1,000 mg daily) + prednisone / prednisolone (up to 10 mg once daily for the standard formulation) or Docetaxel: Single agent chemotherapy will consist of docetaxel given at a recommended dose of 75mg/m2 IV every 3 weeks given in combination with oral prednisone / prednisolone 5mg twice a day (or equivalent) for up to 10 cycles

Primary Outcome Measure

Radiographic Progression-free Survival [ Time Frame: 337days ]

Locations (9)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer CentreOrangeCalifornia92868-
Biogenix Molecular LLCMiamiFlorida33165-
United TheranosticsGlen BurnieMaryland21061-
XCancer OmahaOmahaNebraska68130-
Columbia University Herbert Irving Comphrensive Cancer CenterNew YorkNew York10032
Lisa Sahadi
[email protected]
732-235-2466
Mark Stein (PRINCIPAL_INVESTIGATOR)
University HospitalClevelandOhio44106-
OHSU Knight Cancer CenterPortlandOregon97239-
Intermountain HealthMurrayUtah84107-
Intermountain HealthSalt Lake CityUtah84112-

Find similar trials in Orange, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Chao Family Comprehensive Cancer Centre· Orange, CABiogenix Molecular LLC· Miami, FLUnited Theranostics· Glen Burnie, MDXCancer Omaha· Omaha, NEColumbia University Herbert Irving Comphrensive Cancer Center· New York, NYUniversity Hospital· Cleveland, OH

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