New radiation therapy aims to slow advanced prostate cancer

NCT ID NCT06520345

Disease control Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether adding a targeted radiation drug (lutetium-177 rosopatamab) to standard care can help men with a specific type of advanced prostate cancer that has stopped responding to hormone therapy. The study will enroll 520 men across multiple countries. Participants are randomly assigned to receive either the radiation drug plus standard care or standard care alone. The main goal is to see if the combination delays cancer growth or death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Lutetium-177 rosopatamab tetraxetan (a targeted radiation drug)
What this could lead to: If successful, this could provide a new treatment option that slows cancer progression and extends survival for men with advanced prostate cancer that has stopped responding to hormone therapy.
What could go wrong: This is an early-stage Phase 3 trial, so results are not guaranteed. The radiation drug may cause side effects like fatigue, low blood counts, or kidney issues, and it may not work better than standard care alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 520 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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 of disease progression while receiving this ARPI. Progression must have occurred on the most recent ARPI. A prior ARPI may have been utilized, but no progression on the prior ARPI is allowed (e,g, ARPI was switched due to poor tolerability or due to adverse events). No washout period is required prior to enrollment into this trial. Participants may have received docetaxel in the mCSPC setting as per the CHAARTED or STAMPEDE treatment regimens (up to 6 cycles of docetaxel), provided the last dose of docetaxel was ≥ 6 months prior to screening and ≥ 4 cycles of docetaxel were administered. * 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: 1. Presence of metastases for exclusion: Screening CT and MRI will be assessed to exclude participants with brain metastasis with long-axis\>1cm 2. 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 tumor lesion SUVmax to liver SUVmean derived from a 3 cm 3D spherical region of interest (ROI). PSMA positivity is defined as : At least 1 lesion with PSMA TLR≥2. PSMA exclusion critieria: The presence of any of the following will result in the patient being ineligible for this trial: i) visceral metastatic lesions that are ≥1 cm that have a PSMA TLR\< 1 ii) Lytic bone metastatic lesions with a soft tissue component of at least 1 cm with a TLF \<1. iii) At least one metastatic lymph node lesion with short axis ≥2.5 cm with a TLF\<1. * 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 may be discussed with the medical monitor as needed. * 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 partner of the participant 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 (Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1 \[Clinical Trial Coordination Group {CTCG, 2024}\]). Exclusion Criteria: * 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: 1. Prior malignancy that has been adequately treated and has remained disease-free for at least 3 years (maybe confirmed by a scan, etc.). 2. Adequately treated non-melanoma skin cancer. 3. 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 was ≥6 months prior to screening and ≥4 cycles of docetaxel were administered). * 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 other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. * 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, respiratory, central nervous system, renal, hepatic or hematological organ systems, that might impair the ability to complete this study or could interfere with determination of causality of any adverse effects experienced in this study, or which require treatment that could interact with study treatment, particularly with enzalutamide. * Has received treatment with any PARP inhibitors (i.e., Olaparib) or with any platinum based anti-neoplastic drugs.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castration resistant prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

25 sites in 6 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

Ankara Bilkent City Hospital
NOT_YET_RECRUITING

Ankara, Turkey (Türkiye)
Ankara University Cebeci Hospital
RECRUITING

Ankara, Turkey (Türkiye)
Auckland City Hospital
RECRUITING

Grafton, Auckland, 92024, New Zealand
Austin Health
RECRUITING

Heidelberg, 3084, Australia
Australian Prostate Centre
RECRUITING

Melbourne, Victoria, 3051, Australia

Contact Email: •••••@•••••
Biogenix Molecular LLC
ACTIVE_NOT_RECRUITING

Miami, Florida, 33165, United States
Chao Family Comprehensive Cancer Centre
ACTIVE_NOT_RECRUITING

Orange, California, 92868, United States
Charing Cross Hospital
RECRUITING

London, United Kingdom
Columbia University Herbert Irving Comphrensive Cancer Center
RECRUITING

New York, New York, 10032, United States
GenesisCare Maitland
RECRUITING

East Maitland, 2323, Australia
GenesisCare Murdoch
RECRUITING

Perth, Western Australia, 6150, Australia
GenesisCare North Adelaide
RECRUITING

North Adelaide, 5006, Australia
GenesisCare Tugun
RECRUITING

Tugun, 4224, Australia
Genesiscare Windsor
RECRUITING

Windsor, United Kingdom

Contact Email: •••••@•••••
GensisCare Cabrini
RECRUITING

Malvern, 3144, Australia
Hacettepe University Medical Faculty
RECRUITING

Ankara, Turkey (Türkiye)
INITIO Medical Group
RECRUITING

Burnaby, Canada

Contact Email: •••••@•••••
Intermountain Health
ACTIVE_NOT_RECRUITING

Murray, Utah, 84107, United States
Intermountain Health
ACTIVE_NOT_RECRUITING

Salt Lake City, Utah, 84112, United States
Maslak Acibadem Hospital
RECRUITING

Istanbul, Turkey (Türkiye)
Mater Health Services Pty Ltd
NOT_YET_RECRUITING

Brisbane, 4101, Australia
Nepean Hospital
RECRUITING

Sydney, New South Wales, 2747, Australia
New Zealand Clinical Research - Christchurch
RECRUITING

Christchurch, 8011, New Zealand
OHSU Knight Cancer Center
ACTIVE_NOT_RECRUITING

Portland, Oregon, 97239, United States
Royal Free Hospital
NOT_YET_RECRUITING

London, United Kingdom
Royal North Shore Hospital
RECRUITING

Saint Leonards, 2065, Australia
Sunnybrook Research Institute
RECRUITING

Toronto, Canada
United Theranostics
ACTIVE_NOT_RECRUITING

Glen Burnie, Maryland, 21061, United States
University College London Hospitals
RECRUITING

London, United Kingdom
University Hospital
ACTIVE_NOT_RECRUITING

Cleveland, Ohio, 44106, United States
Westmead Hospital
RECRUITING

Sydney, New South Wales, 2143, Australia
Wollongong Hospital
RECRUITING

Wollongong, New South Wales, 2500, Australia
XCancer Omaha
ACTIVE_NOT_RECRUITING

Omaha, Nebraska, 68130, United States

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