The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)
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
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
Treatments tested in this trial
- 177Lu-TLX591
- Enzalutamide
- Abiraterone
- Docetaxel
Treatment groups
520 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov