Radioactive therapy targets tough prostate cancers in major trial

NCT ID NCT04647526

Disease control Sponsor: POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests a radioactive drug called Lu-177-PNT2002 in 455 men with metastatic castration-resistant prostate cancer that has worsened after hormone therapy. The drug seeks out and delivers radiation directly to cancer cells. The main goal is to see if it delays cancer growth compared to standard hormone treatments.

What this could mean

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

Active substance: Lu-177-PNT2002 (a radioactive drug that targets prostate cancer cells)
What this could lead to: If it works, this could offer a new treatment option for men with advanced prostate cancer that has stopped responding to hormone therapy, potentially slowing disease progression.
What could go wrong: This is a phase 3 trial, but results are not yet final. The treatment involves radiation, which may cause side effects like fatigue or low blood counts. It may not work for everyone.

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

455 people

The number who actually took part.

Started

Feb 2021

Expected to finish

Mar 2028

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: 1. Male aged 18 years or older. 2. Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. 3. Ineligible or averse to chemotherapeutic treatment options. 4. Patients must have progressive mCRPC at the time of consent based on at least 1 of the following criteria: 1. Serum/plasma PSA progression defined as increase in PSA greater than 25% and \>2 ng/mL above nadir, confirmed by progression at 2 time points at least 3 weeks apart. 2. Soft-tissue progression defined as an increase ≥20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or a new lesion. 3. Progression of bone disease defined as the appearance of two or more new lesions by bone scan. 5. Progression on previous treatment with one ARAT (abiraterone or enzalutamide or darolutamide or apalutamide) in either the CSPC or CRPC setting. 6. PSMA-PET scan (i.e., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by the sponsor's central reader. 7. Castrate circulating testosterone levels (\<1.7 nmol/L or \<50 ng/dL). 8. Adequate organ function, independent of transfusion: 1. Bone marrow reserve: * i. White blood cell (WBC) count ≥2.5 × 10\^9/L OR absolute neutrophil count (ANC) ≥1.5 × 10\^9/L. * ii. Platelets ≥100 × 10\^9/L. * iii. Hemoglobin ≥8 mmol/L. 2. Liver function: * i. Total bilirubin ≤1.5 × institutional upper limit of normal (ULN). For patients with known Gilbert's syndrome, ≤3 × ULN is permitted. * ii. ALT or AST ≤3.0× ULN. 3. Renal function: * i. Serum/plasma creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min based on Cockcroft-Gault formula (for patients in France, serum/plasma creatinine ≤1.5 × ULN or CrCl ≥60 mL/min based on Cockcroft-Gault formula). 4. Albumin ≥30 g/L. 9. Human immunodeficiency virus-infected patients who are healthy and have a low risk of acquired immunodeficiency syndrome-related outcomes are included in this trial. 10. For patients who have partners who are pregnant or of childbearing potential: a condom is required along with a highly effective contraceptive method during the study and for 6 months after last study drug administration. Such methods deemed highly effective include a) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, b) progestogen-only hormonal contraception associated with inhibition of ovulation, c) intrauterine device (IUD), d) intrauterine hormone-releasing system (IUS), e) bilateral tubal occlusion, f) vasectomy, g) true sexual abstinence: when this is in line with the preferred and usual lifestyle of the subject \[periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to IMP, and withdrawal are not acceptable methods of abstinence\]. 11. Willing to initiate ARAT therapy (either enzalutamide or abiraterone), pre-specified by investigator, if randomized to Treatment Arm B. 12. ECOG performance status 0 to 1. 13. Willing and able to comply with all study requirements and treatments (including 177Lu PNT2002) as well as the timing and nature of required assessments. 14. Signed informed consent. Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: 1. If noted in pathology report, prostate cancer with known significant (\>10% present in cells) sarcomatoid or spindle cell or neuroendocrine components. Any small cell component in the cancer should result in exclusion. 2. Prior treatment for prostate cancer ≤28 days prior to randomization, with the exclusion of first-line local external beam, ARAT, luteinizing hormone-releasing hormone (LHRH) therapy, or non-radioactive bone-targeted agents. 3. Any prior cytotoxic chemotherapy for CRPC (e.g., cabazitaxel or docetaxel); chemotherapy for hormone-sensitive prostate cancer (HSPC) is allowed if the last dose was administered \>1 year prior to consent. 4. Prior treatment with systemic radionuclides (e.g. radium-223, rhenium-186, strontium 89). 5. Prior immuno-therapy, except for sipuleucel-T. 6. Prior PSMA-targeted radioligand therapy, e.g., Lu-177-PSMA-617, I 131-1095. 7. Prior poly ADP ribose polymerase (PARP) inhibitor for prostate cancer. 8. Patients who progressed on 2 or more lines of ARATs. 9. Patients receiving bone-targeted therapy (e.g. denosumab, zoledronic acid) not on stable doses for at least 4 weeks prior to randomization. 10. Administration of an investigational agent ≤60 days or 5 half-lives, whichever is shorter, prior to randomization. 11. Major surgery ≤30 days prior to randomization. 12. Estimated life expectancy \<6 months as assessed by the principal investigator. 13. Presence of liver metastases \>1 cm on abdominal imaging. 14. A superscan on bone scan defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity. 15. Dose escalation or initiation of opioids for cancer-related pain ≤30 days prior to consent up to and including randomization. 16. Known presence of central nervous system metastases. 17. Contraindications to the use of planned ARAT therapy, \[Ga-68\]-PSMA-11, \[F-18\]-DCFPyL or \[Lu-177\]-PNT2002 therapy, including but not limited to the following: * Hypersensitivity to \[Ga-68\]-PSMA-11, \[F-18\]-DCFPyL or \[Lu-177\]-PNT2002 excipients (Diethylenetriaminepentaacetic acid (DTPA), Sodium ascorbate, Lascorbic acid, Sodium gentisate, HCl, Sodium hydroxide). * Recent myocardial infarction or arterial thrombotic events (in the past 6 months) or unstable angina (in the past 3 months), bradycardia or left ventricular ejection fraction measurement of \< 50%. * History of seizures in patients planned to receive enzalutamide. 18. Active malignancy other than low-grade non-muscle-invasive bladder cancer and non-melanoma skin cancer. 19. Concurrent illness that may jeopardize the patient's ability to undergo study procedures. 20. Serious psychological, familial, sociological, or geographical condition that might hamper compliance with the study protocol and follow-up schedule. Patients that travel need to be capable of repeated visits even if they are on the control arm. 21. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. 22. Concurrent serious (as determined by the investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure (see 12.1 Appendix 1), unstable ischemia, uncontrolled symptomatic arrhythmia, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.

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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

Contacts and locations

Locations

Arizona Institute of Urology (AIU) - Tucson

Tucson, Arizona, 85704, United States
Astera Cancer Care

East Brunswick, New Jersey, 08816, United States
BC Cancer - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada
CHU of Quebec - Laval University

Québec, Quebec, G1R 2J6, Canada
CHUM - University Hospital of Montreal

Montreal, Quebec, H2X 3E4, Canada
Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, 90048, United States
Center Jean Perrin, Department of Medical Oncology

Clermont-Ferrand, 63011, France
Charing Cross Hospital, Department of Medical Oncology

London, United Kingdom
Chesapeake Urology Associates (CUA) P.A.

Towson, Maryland, 21204, United States
Claude Huriez Hospital

Lille, 59037, France
Dallas VA Medical Center, Nuclear Medicine Service

Dallas, Texas, 75216, United States
Erasmus University Medical Center Rotterdam

Rotterdam, 3015 GD, Netherlands
Excel Diagnostics & Nuclear Oncology Center

Houston, Texas, 77402, United States
Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States
Greater Dayton Cancer Center

Kettering, Ohio, 45409, United States
H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States
Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States
Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada
Karmanos Cancer Center

Detroit, Michigan, 48201, United States
La Timone Hospital, Nuclear Medicine Department

Marseille, 13385, France
Leon Berard Center

Lyon, 69373, France
London Health Sciences Center - Victoria Hospital

London, Ontario, N6A 5W9, Canada
Montpellier Cancer Institute, Department of Nuclear Medicine

Montpellier, 34298, France
New Mexico Oncology Hematology Consultants Ltd., New Mexico Cancer Center

Albuquerque, New Mexico, 87109, United States
New York Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10065, United States
Norrlands University Hospital, Department of Radiation Sciences, Oncology

Umeå, Sweden
Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2Y9, Canada
Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States
Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada
Radboud University Medical Center (Radboudumc)

Nijmegen, Netherlands
Royal Marsden NHS Foundation Trust - Institute of Cancer Research

Sutton, United Kingdom
Sahlgrenska University Hospital

Gothenburg, 41345, Sweden
Saint Louis University Hospital

St Louis, Missouri, 63110, United States
St. Antonius Hospital

Nieuwegein, Netherlands
Stanford Cancer Institute

Palo Alto, California, 94305, United States
Sunnybrook Research Institute, Odette Cancer Center

Toronto, Ontario, M4N 3M5, Canada
Swedish Cancer Institute Research

Seattle, Washington, 98104, United States
Tenon Hospital, Department of Medical Oncology

Paris, 75020, France
Tri-State Urologic Services

Cincinnati, Ohio, 45212, United States
Tulane University Medical Center

New Orleans, Louisiana, 70112, United States
UC Irvine Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States
UT Southwestern Medical Center

Dallas, Texas, 75390, United States
University of California Los Angeles, Nuclear Medicine Clinic

Los Angeles, California, 90095, United States
University of Colorado Hospital

Aurora, Colorado, 80045, United States
University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States
University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States
University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States
University of Michigan Hospitals

Ann Arbor, Michigan, 48109, United States
Urology Cancer Center, PC

Omaha, Nebraska, 68130, United States
VA Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States
VA St. Louis Health Care System

St Louis, Missouri, 63106, United States
Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States

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