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Compares treatment options for Metastatic Castration-resistant Prostate Cancer
Official title The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)
ClinicalTrials.gov ID: NCT06520345
What this study is testing
What is 177Lu-TLX591?
177Lu-TLX591 is an investigational medicine, being studied as a potential treatment for metastatic castration-resistant prostate cancer.
Also referred to as Lutetium (177Lu) rosopatamab tetraxetan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Must have received a minimum of 12 weeks of prior therapy on an ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide), received in either...
You likely can't join if
- Is unable to understand or is unwilling to sign a written informed consent document or to follow investigational procedures in the opinion of the...
- Has PC associated with pathological findings consistent with small cell or any histology other than adenocarcinoma of the prostate. If there are...
- Participants with a history of other malignancies that could significantly impact life expectancy or interfere with disease assessment will be...
- 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.
- Superficial (non-muscle invasive) bladder cancer that is controlled and stable.
See the full eligibility criteria
Who can join
- 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...
- Must have received a minimum of 12 weeks of prior therapy on an ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide), received in either the mCSPC, nmCRPC, or mCRPC treatment settings, with documented evidence...
- 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:
- Two consecutive rising PSA values assessed sequentially at least one week apart, with the final measurement required to be a minimum of 2.0 ng/mL for study entry. Only the last measurement must meet or exceed 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 PCWG3. Any ambiguous results are to be confirmed by other imaging modalities (e.g., CT or MRI scan).
- Have disease that is PSMA-positive, as demonstrated by a 68Ga-PSMA-11 PET/CT or PET/MRI scan and confirmed as eligible by the Sponsor's appointed BICR. Imaging-based eligibility review will be performed in two stages:
- Presence of metastases for exclusion: Screening CT and MRI will be assessed to exclude participants with brain metastasis with long-axis\>1cm
- PSMA PET eligibility: Screening 68Ga-PSMA-11 PET/CT or PET/MRI will be assessed along with CT, MRI, and bone scans utilizing tumor to liver ratio (TLR) for PSMA positivity-based exclusion. TLR is defined as the ratio of...
- Must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., surgery, local radiotherapy, ARPI, chemotherapy, etc.) with the exception of alopecia. Specific conditions...
- Have adequate organ function at Screening: Bone marrow:
- Platelets ≥150×109/L.
- Absolute neutrophil count ≥1.5 x 109/L.
- Hemoglobin \>10g/dL (with no red blood cell transfusion in the previous 4 weeks). Liver function:
- Total bilirubin ≤ 1.5× the upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3× ULN is permitted.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3× ULN. Renal function:
- Creatinine clearance ≥45 mL/min determined using the Cockcroft-Gault formula.
- Must understand the study and agree to adhere to all protocol requirements.
- Participants must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution to protect their contacts and the public, especially if a female...
- 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 (Recommendations related to contraception and...
What rules you out
- 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.
- Participants with a history of other malignancies that could significantly impact life expectancy or interfere with disease assessment will be excluded. Exceptions apply to participants with:
- 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.
- Superficial (non-muscle invasive) bladder cancer that is controlled and stable.
- Has received prior treatment with monoclonal antibody (mAb) J591 or HuJ591 or any other PSMA targeted therapy.
- Have received chemotherapy in the mCRPC or non-metastatic prostate cancer (nmCRPC) settings (note: prior docetaxel use in the mCSPC setting with CHAATERED or STAMPEDE regimens is permitted if the last dose of therapy...
- Has known allergies, hypersensitivity, or intolerance to the investigational drug or its excipients.
- Has received prior systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, or biological therapy) and/or radiation therapy within 4 weeks of enrolment (excluding ARPI and/or LHRH analogues). OR are receiving...
- Has received prior treatment with radioisotopes, including but not limited to: 89Strontium, 153Samarium, 186Rhenium, 188Rhenium, 223Radium, or hemi-body irradiation within 6 months prior to enrolment.
- Has received other investigational therapy within 4 weeks of enrolment.
- Has known brain metastases with long-axis ≥1cm, or liver metastases with long-axis ≥1cm, or lytic bone metastases with long-axis ≥1cm.
- Has a history of seizure and/or stroke within the past 6 months.
- Has clinical or radiologic findings indicative of impending spinal cord compression or experience symptomatic spinal cord compression.
- Has evidence of a serious active or sub-clinical infection or angina pectoris (New York Heart Association [NYHA] Class III or IV), significantly prolonged QT interval or other serious illness(es) involving the cardiac...
- Has received treatment with any PARP inhibitors (i.e., Olaparib) or with any platinum based anti-neoplastic drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Miami, Florida, United States
- Glen Burnie, Maryland, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Murray, Utah, United States
- Salt Lake City, Utah, United States
- Sydney, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Brisbane, Australia
- East Maitland, Australia
- Heidelberg, Australia
- Malvern, Australia
- North Adelaide, Australia
- Saint Leonards, Australia
- Tugun, Australia
+ 8 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Miami, Florida, United States; Glen Burnie, Maryland, United States; Omaha, Nebraska, United States; New York, New York, United States; Cleveland, Ohio, United States and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.