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Radioactive bullet targets tough prostate cancer in major trial

NCT ID NCT04689828

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 7 times

Summary

This phase 3 trial tests a radioactive drug called 177Lu-PSMA-617 in 469 men with advanced prostate cancer that has stopped responding to hormone therapy. The drug seeks out and delivers radiation directly to cancer cells. Researchers compare it to switching to another hormone therapy. The main goal is to see if it delays cancer growth or improves survival.

What this could mean

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

Active substance
177Lu-PSMA-617 (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 delaying disease progression.
What could go wrong
This is a late-stage trial, but results are not yet final. The drug may not improve survival or could cause side effects like bone marrow suppression or kidney damage. It is only for men whose tumors show a specific marker on a PET scan.

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

469 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Sep 2026

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 to 100 years

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: * Signed informed consent must be obtained prior to participation in the study. * Participants must be adults \>= 18 years of age. * Participants must have an ECOG performance status of 0 to 1. * Participants must have histological pathological, and/or cytological confirmation of adenocarcinoma of the prostate. * Participants must be 68Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the sponsor's central reader. * Participants must have a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * Participants must have progressed only once on prior second generation ARDT (abiraterone, enzalutamide, darolutamide, or apalutamide). * First generation androgen receptor inhibitor therapy (e.g. bicalutamide) is allowed but not considered as prior ARDT therapy. * Second generation ARDT must be the most recent therapy received. * Participants must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria: * Serum/plasma PSA progression defined as 2 increases in PSA measured at least 1 week apart. The minimal start value is 2.0 ng/mL; 1.0 ng/mL is the minimal starting value if confirmed rise in PSA is the only indication of progression. * Soft-tissue progression defined \[PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016)\]. * Progression of bone disease: two new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria (Scher et al 2016)). * Participants must have \>= 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained prior to randomization. * Participants must have recovered to =\< Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, etc.) except alopecia. * 11\. Participants must have adequate organ function: * Bone marrow reserve: * ANC \>= 1.5 x 109/L * Platelets \>= 100 x 109/L * Hemoglobin \>= 9 g/dL * Hepatic: * Total bilirubin \< 2 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome =\< 3 x ULN is permitted. * ALT or AST =\< 3.0 x ULN OR =\< 5.0 x ULN for participants with liver metastases. * Renal: * eGFR \>= 50 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation. * Albumin \>= 2.5 g/dL. -. Candidates for change in ARDT as assessed by the treating physician: • Participants cannot have previously progressed nor had intolerable toxicity to both enzalutamide and abiraterone. Exclusion Criteria: * Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. * Previous PSMA-targeted radioligand therapy. * Prior treatment with cytotoxic chemotherapy for castration resistant or castrate sensitive prostate cancer (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy \[including monoclonal antibodies\]. \[Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed\]. * Any investigational agents within 28 days prior to day of randomization. * Known hypersensitivity to any of the study treatments or its excipients or to drugs of similar classes. -. Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, or investigational therapy. * Transfusion or use of bone marrow stimulating agents for the sole purpose of making a participant eligible for study inclusion. * Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), asymptomatic and neurologically stable without corticosteroids. Participants with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. * Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. * History or current diagnosis of the following ECG abnormalities indicating significant risk of safety for study participants: * Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block). * History of familial long QT syndrome or known family history of Torsades de Pointe. * Cardiac or cardiac repolarization abnormality, including any of the following: History of myocardial infarction (MI), angina pectoris, or CABG within 6 months prior to starting study treatment. * Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to New York Heart Association class III or IV congestive heart failure, 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. * HIV-infected participants who are at a low risk of AIDS-related outcomes may participate in this trial. * Participants with an active documented COVID-19 infection (any grade of disease severity) at time of informed consent may be included only when completely recovered (in accordance with local guidance). * Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free and treatment free for more than 3 years prior to randomization, are eligible, as are participants with adequately treated non-melanoma skin cancer and superficial bladder cancer. * Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF. * Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: Participant with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best available standard of care (incl. pads, drainage) are allowed. * History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study. * Any condition that precludes raised arms position. * Eligible for treatment(s) other than ARDT based on presence of any mutations or biomarkers that are known as predictors of better response (e.g., AR-V7 or BRCA). * Not able to understand and to comply with study instructions and requirements.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer prostate neoplasm

As listed by the trial registrant

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

Prostatic neoplasms

Contacts and locations

Locations

  • Beth Israel Deaconess Med Ctr

    Boston, Massachusetts, 02215, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Duke Univ Medical Center

    Durham, North Carolina, 27710, United States

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Ctr

    New York, New York, 10065, United States

  • Mount Sinai Hosp Med School

    New York, New York, 10029, United States

  • NYU Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016, United States

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68154, United States

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020, Austria

  • Novartis Investigative Site

    Linz, 4020, Austria

  • Novartis Investigative Site

    Vienna, 1090, Austria

  • Novartis Investigative Site

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Novartis Investigative Site

    Brussels, 1200, Belgium

  • Novartis Investigative Site

    Ghent, 9000, Belgium

  • Novartis Investigative Site

    Liège, 4000, Belgium

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H2X 1R9, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2, Canada

  • Novartis Investigative Site

    Olomouc, 779 00, Czechia

  • Novartis Investigative Site

    Angers, 49055, France

  • Novartis Investigative Site

    Bordeaux, 33076, France

  • Novartis Investigative Site

    Clermont-Ferrand, 63011, France

  • Novartis Investigative Site

    Lyon, 69373, France

  • Novartis Investigative Site

    Paris, 75970, France

  • Novartis Investigative Site

    Villejuif, 94800, France

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    München, 80377, Germany

  • Novartis Investigative Site

    Maastricht, Limburg, 6229 HX, Netherlands

  • Novartis Investigative Site

    Nijmegen, 6525 GA, Netherlands

  • Novartis Investigative Site

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    Gliwice, Silesian Voivodeship, 44-101, Poland

  • Novartis Investigative Site

    Bratislava, 83310, Slovakia

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    El Palmar, Murcia, 30120, Spain

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Valencia, Valencia, 46009, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28040, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Madrid, 28222, Spain

  • Novartis Investigative Site

    Málaga, 29010, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Gothenburg, 413 45, Sweden

  • Novartis Investigative Site

    Lund, 221 85, Sweden

  • Novartis Investigative Site

    Stockholm, 17176, Sweden

  • Novartis Investigative Site

    Baden, 5404, Switzerland

  • Novartis Investigative Site

    Lausanne, 1011, Switzerland

  • Novartis Investigative Site

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    Guildford, Surrey, GU2 7XX, United Kingdom

  • Novartis Investigative Site

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Novartis Investigative Site

    Coventry, CV2 2DX, United Kingdom

  • Novartis Investigative Site

    London, EC1A 7BE, United Kingdom

  • Novartis Investigative Site

    London, NW1 2BU, United Kingdom

  • Novartis Investigative Site

    London, NW3 2QG, United Kingdom

  • Novartis Investigative Site

    Middlesbrough, TS4 3BW, United Kingdom

  • Onco Hemato Asso of SW Virginia

    Roanoke, Virginia, 24014, United States

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218, United States

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43221, United States

  • Tulane Uni Health Sciences Center

    New Orleans, Louisiana, 70112, United States

  • Uni Of TX MD Anderson Cancer Cntr

    Houston, Texas, 77030, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • Urology Cancer Center PC

    Omaha, Nebraska, 68130, United States

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • WA Uni School Of Med

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.