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

ConditionMetastatic Castration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorTelix Pharmaceuticals (Innovations) Pty Limited

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be a male, at least 18 years old, with documented adenocarcinoma of the prostate defined by histological / pathological confirmation.

Be of ECOG Performance Status 0, 1, or 2 and have an estimated life expectancy of ≥6 months from Day 1.

Have metastatic disease (defined as ≥1 metastatic lesion present on baseline CT, MRI or bone scintigraphy).

Have castration-resistant PC (defined as disease progressing despite castration by orchiectomy or ongoing use of luteinizing hormone-releasing hormone [LHRH] analogues) and must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L) at Screening

Disqualifiers

Is unable to understand or is unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the Investigator.

Has PC associated with pathological findings consistent with small cell or any histology other than adenocarcinoma of the prostate. If there are minor (<20%) elements of neuroendocrine histology, this is acceptable.

Prior malignancy that has been adequately treated and has remained disease-free for at least 3 years (maybe confirmed by a scan, etc.).

Adequately treated non-melanoma skin cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

520 Participants
are divided into 2 treatment groups
Group A: 177Lu-TLX591 + Enzalutamide or Abiraterone or DocetaxelExperimental treatment 4 interventions
Group B: Control Arm (Enzalutamide or Abiraterone or Docetaxel)Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

Radiographic Progression-free Survival

time from randomization to disease progression confirmed by central independent radiology review according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (which incorporates Response Evaluation Criteria in Solid Tumors, RECIST 1.1, for soft tissue lesions), or death (whichever occurs first)

Time frame
337days

Secondary outcomes

1

Overall Survival

Defined as the time from randomization, until death from any cause.

Time frame
5 years
2

Objective Response Rate (ORR)

Tumor response in terms of PCWG3 criteria (which incorporates RECIST 1.1 for soft tissue lesions).

Time frame
337days
3

Time to a first symptomatic skeletal event (SSE)

Time to a first SSE, defined as the use of external beam radiation to relieve bone pain, or occurrence of a new symptomatic pathological fracture (vertebral or non-vertebral), or occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.

Time frame
337days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Telix Pharmaceuticals (Innovations) Pty Limited

Lead sponsor

Source ClinicalTrials.gov
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