A Multinational, Multicenter, Prospective, Randomized, Controlled, Open Label Phase 3 Study With Best Standard of Care With and Without 177Lu-DOTA-rosopatamab for Patients With PSMA Expressing Metastatic Castration-resistant Prostate Cancer Progressing Despite Prior Treatment With a Novel Androgen Axis Drug

Who is this study for? Patients with Metastatic Prostate Cancer
What treatments are being studied? 177Lu-DOTA-rosopatamb
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This multinational, multicenter, prospective, randomized, controlled, open label Phase 3 study is designed to investigate and confirm the benefits and risks associated with the PSMA-targeted antibody, 177Lu DOTA rosopatamab administered together with Standard of Care (SoC), as compared to the best SoC alone. The phase 3 will be conducted in patients with metastatic castration-resistant PC (mCRPC) that expresses PSMA and has progressed despite prior treatment with a novel androgen axis drug (NAAD).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

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

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

• Have metastatic disease (≥1 metastatic lesions present on baseline CT, MRI, or bone scan imaging).

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

• In the mCRPC setting, must have received a minimum of 12 weeks of prior therapy with a NAAD, either enzalutamide or abiraterone plus prednisone.

• Should have received one line of prior taxane therapy or have refused or be ineligible for taxanes

• Have a disease that is progressing at study entry, despite a castrate testosterone level (\<50 ng/dL or \<1.7 nmol/L), by the demonstration of at least one of the following:

∙ Rising PSA values done in sequence at least 1 week apart and with a minimal starting value of 2.0 ng/mL.

‣ Progressive disease or new lesion(s) in the viscera or lymph nodes as per RECIST1.1 or in bone as per Prostate Cancer Working Group 3 \[PCWG3; Scher et al., 2016\]). Any ambiguous results are to be confirmed by other imaging modality (e.g., CT or MRI scan).

• Have disease that is PSMA positive, as demonstrated by a 68Ga-PSMA11 PET/CT scan and confirmed as eligible by the Sponsor's central reader (patient must have at least one site of metastatic disease with SUVmax ≥1.5 times the SUV of normal liver). If the disease meets the criteria for PSMA positivity, but there is one or more soft tissue lesion of ≥ 2 cm that is not PSMA positive, then the patient is to be excluded on the grounds that there is substantial disease which might not respond to the therapy.

• Must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., surgery, local radiotherapy, NAAD, chemotherapy, etc.).

⁃ Can be receiving a bisphosphonate or denosumab regimen provided that the patient has been receiving and tolerating this treatment for ≥30 days prior to randomization.

⁃ Have adequate organ function at Screening:

⁃ a. Bone marrow: i. Platelets ≥150×109/L. ii. Absolute neutrophil count \>1.5×109/L. iii. Hemoglobin ≥10g/dL (no red blood cell transfusion in the previous 4 weeks).

⁃ b. Liver function: i. Total bilirubin \< 1.5×the upper limit of normal (ULN). For patients with known Gilbert's Syndrome \<3×ULN is permitted. ii. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \<3×ULN OR \<5×ULN for patients with liver metastases. c. Renal function: i. Serum/plasma creatinine \<1.5×ULN or creatinine clearance ≥50 mL/min determined using the Cockcroft \& Gault formula.

⁃ Have the capacity to understand the study and be able and willing to comply with all protocol requirements.

⁃ Patients must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution in order to protect their contacts and the general public, especially if a female partner of the patient is or could be pregnant.

⁃ Must agree to practice adequate precautions to prevent pregnancy in a partner and to avoid potential problems associated with radiation exposure to the unborn child (Refer to Clinical Trials Facilitation Group, 2020: Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1, CTFG, 2020).

Locations
Other Locations
Australia
Monash Health
RECRUITING
Clayton
Austin Health
RECRUITING
Melbourne
'GenesisCare Murdoch'
RECRUITING
Murdoch
Westmead Hospital
RECRUITING
Westmead
Princess Alexandra Hospital
ACTIVE_NOT_RECRUITING
Woolloongabba
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Contact Information
Primary
Brenda Cerqueira, M.Sc
brenda.cerqueira@telixpharma.com
+61 83180090
Backup
Vanessa Penna, Ph.D
vanessa.penna@telixpharma.com
+61 3 9093 3880
Time Frame
Start Date: 2023-08-29
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 392
Treatments
Experimental: Group A
Two single intravenous (IV) injections of 76 mCi each (equivalent to a 45 mCi/m2 dose in a standard 1.7m2 individual) of 177Lu-DOTA- rosopatamab, given 14 days apart, plus best Standard of Care
Active_comparator: Group B
Participants will receive the Standard of Care
Experimental: Biodistribution and Dosimetry Sub-Study
Two single intravenous (IV) injections of 76 mCi each (equivalent to a 45 mCi/m2 dose in a standard 1.7m2 individual) of 177Lu-DOTA- rosopatamab, given 14 days apart, plus best Standard of Care
Related Therapeutic Areas
Sponsors
Leads: Telix Pharmaceuticals (Innovations) Pty Ltd

This content was sourced from clinicaltrials.gov

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