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Radioactive therapy aims to stall prostate cancer spread without hormone drugs

NCT ID NCT05939414

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 02, 2026 · Updated 5 times

Summary

This phase 3 trial tests a radioactive drug called lutetium-177 vipivotide tetraxetan in 450 men whose prostate cancer has returned and spread to a few spots after initial treatment. The drug targets a protein on cancer cells and delivers radiation directly to them. The goal is to see if it can delay the cancer from spreading further and postpone the need for hormone therapy, which often has tough side effects.

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 vipivotide tetraxetan (a radioactive drug that targets prostate cancer cells)
What this could lead to
If it works, this could offer a new way to control early-stage prostate cancer that has spread to a few spots, delaying the need for hormone therapy and helping men maintain quality of life longer.
What could go wrong
This is a large phase 3 trial, but the drug is radioactive and may cause side effects like fatigue or blood cell changes. It is not a cure, and it is unclear if it will work better than current options for all patients.

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 450 people

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

Started

Mar 2024

Expected to finish

Oct 2031

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.

Key Inclusion criteria: 1. Histologically confirmed prostate cancer prior to randomization 2. Participants must have biochemically recurrent disease after definitive treatment to prostate by Radical Prostatectomy ((RP), (alone or with post-operative radiation to prostate bed/pelvic nodes)) or External beam Radiation Therapy (EBRT), (prostate alone or prostate with seminal vesicle and/or pelvic nodes) and/or brachytherapy prior to randomization. Biochemical recurrence (BCR) is defined as: nadir PSA + 2 ng/mL post XRT (if participant received-radiation therapy to intact prostate) and PSA \> 0.2 ng/mL and rising post RP (with or without post-operation Radiation Therapy (RT)) 3. Participants must have OMPC with 1-5 PSMA -positive metastatic lesions on screening PSMA PET/CT scan (with either gallium (68Ga) gozetotide or piflufolastat (18F)) as visually assessed by BIRC. For definition of PSMA PET positivity, please refer to Section 8.1 and the Imaging Manual. Metastatic lesions may include regional/pelvic lymph nodes (N1), distant lymph nodes (M1a), bone (M1b), lung and others visceral (M1c) except liver and brain classified using American Joint Committee on Cancer (AJCC) 8. When counting the number of oligometastatic lesions, each lesion is counted as distinct metastasis irrespective of its anatomical location (e.g., one pelvic and one extra-pelvic lymph node will be counted as two metastatic lesions) 4. At least 1 PSMA-positive lesion must be a distant metastasis (M1) per AJCC8 classification at screening. For AJCC M staging, PSMA PET/CT information should be used 5. Participants must have a negative CI for M1 disease at screening. Note: * For a participant not to be eligible, CI positive M1 lesions should be unequivocal in CI scans, i.e., potentially not attributable to findings thought to represent something other than tumor (e.g., degenerative, or post-traumatic changes or Paget's disease in bone lesions). For CI assessments, bone lesions must be assessed by bone scan only and soft tissue lesions must be assessed by CT/MRI scans only at screening. * Prior knowledge of PSMA PET positivity should not influence the radiologist (reader) in determination of CI positivity. Two different readers will be involved, one reader for PSMA PET/CT scan and one reader for CI: Reader will be blinded to PSMA PET scan results while reading CI scans. Reader should not modify their assessment of CI scans (e.g. changing a lesion previously identified as equivocal in CI to unequivocal) after reading the PSMA PET scan. Similarly, biopsy positivity should not influence the reader in the assessment of CI positivity. More details on the reading paradigm will be provided in the imaging charter * MRI for radiation treatment planning may show M1 disease but this will not exclude the participant from the study if the lesion is deemed negative per baseline CT or bone scans * Participants with pelvic disease (N1) seen in CI are allowed if the local spread is below common iliac bifurcation (per AJCC 8 definition of local disease) * Distant lymph node disease (M1a) that is visible per CI and less than 10mm in the short axis is not exclusionary irrespective of PSMA PET positivity. * If a previously surgically removed lesion was unequivocal for M1 by bone scan or CT, the participant is not eligible. 6. All metastatic lesions detected at screening must be amenable to SBRT 7. Non-castration testosterone level \>100 ng/dL at screening Key Exclusion criteria: 1. Participants with de novo OMPC at screening 2. Unmanageable concurrent bladder outflow obstruction or urinary incontinence at screening. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best available standard of care (incl. pads, drainage) are allowed 3. Prior therapy with: 1. ADT (including bilateral orchiectomy) and ARPIs used for metastatic prostate cancer treatment * Participants who received AR-directed therapy, whether ADT or an ARPI or both, as neoadjuvant or adjuvant therapy as a component of their primary therapy, are eligible provided that they discontinued therapy ≥12 months prior to randomization for ADT (i.e., 12 months after the last day of the last injection) or ≥3 months if ARPI was given as monotherapy. ARPI's as a term includes both contemporary androgen synthesis inhibitors (e.g., abiraterone, galeterone, and orteneronel), and receptor inhibitors (enzalutamide, apalutamide and darolutamide). * Patients who biochemically relapsed after primary therapy may also have had treatment with AR directed therapy and participants who had SBRT with ADT are also eligible provided that the ARPI +/- ADT or ADT alone was terminated ≥12 months prior to randomization for ADT (i.e., 12 months after the last day of the last injection) or ≥3 months if ARPI was given as monotherapy. * Participants who received first generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) for biochemical recurrence or adjuvant/neoadjuvant therapy are eligible provided that they discontinued therapy ≥3 months prior to randomization. * Participants who have discontinued ADT due to disease progression are not eligible (i.e., Castration-Resistant Prostate Cancer (CRPC) participants) 2. Other hormonal therapy. e.g., •Use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethimide) if used in the context of prostate cancer treatment. Same medications are allowed if used for other indications: e.g., Benign Prostatic Hyperplasia (BPH), if stopped ≥3 months before randomization. 3. Radiopharmaceutical agents (e.g., Strontium-89, PSMA-targeted radioligand therapy) 4. Immunotherapy (e.g., sipuleucel-T) 5. Chemotherapy, except if administered in the adjuvant/neoadjuvant setting completed \> 12 months before randomization 6. Any other investigational or systemic agents for metastatic disease 4. Radiation therapy external beam radiation therapy (EBRT) and brachytherapy within 28 days before randomization 5. Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, hormonal therapy (see ADT initiation guidance in Section 6.8.2), Poly Adenosine Diphosphate-Ribose Polymerase (PARP) inhibitor, biological therapy or investigational therapy 6. Diagnosed at screening 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/treatment free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer and superficial bladder cancer. 7. History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as: * Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree Atrioventricular (AV) block without a pacemaker * History of familial long QT syndrome or known family history of Torsades de Pointe 8. Participants in immediate need of ADT or other systemic therapy as assessed by the investigator. In addition, investigators should only enroll participants who are committed to delay castration in accordance with the scope of the study and are willing to wait to start systemic therapy until distant progression (MFS event) as assessed by CI (consisting with existing treatment guidelines) and confirmed by BIRC is reached. This must be discussed with the participants before ICF is signed. Other protocol defined Inclusion/Exclusion may apply.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma

As listed by the trial registrant

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

Oligometastatic prostate cancer (OMPC)

How to take part

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

  1. The places running it

    141 sites in 27 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Associated Med Professionals of NY

    RECRUITING

    Syracuse, New York, 13210, United States

  • BAMF Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Beth Israel Deaconess Med Ctr

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Blue Ridge Cancer Center

    RECRUITING

    Wytheville, Virginia, 24382, United States

  • Cancer Specialists of North Florida

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Dayton Physicians

    RECRUITING

    Kettering, Ohio, 45409, United States

  • East Carolina University

    RECRUITING

    Greenville, North Carolina, 27858, United States

  • East Jefferson Hospital

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Highlands Oncology Group

    RECRUITING

    Fayetteville, Arkansas, 72703, United States

  • Johns Hopkins Kimmel Com Cancer Ctr

    RECRUITING

    Baltimore, Maryland, 21231, United States

  • Mary Bird Perkins Cancer Center

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Ctr

    RECRUITING

    New York, New York, 10065, United States

  • Montefiore Hospital

    RECRUITING

    The Bronx, New York, 10467-2490, United States

  • Novartis Investigative Site

    RECRUITING

    CABA, Buenos Aires, C1426ANZ, Argentina

  • Novartis Investigative Site

    RECRUITING

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    RECRUITING

    Caba, C1431FWO, Argentina

  • Novartis Investigative Site

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Novartis Investigative Site

    RECRUITING

    Herston, Queensland, 4029, Australia

  • Novartis Investigative Site

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Novartis Investigative Site

    RECRUITING

    Malvern, Victoria, 3144, Australia

  • Novartis Investigative Site

    RECRUITING

    Linz, 4020, Austria

  • Novartis Investigative Site

    RECRUITING

    Vienna, 1090, Austria

  • Novartis Investigative Site

    RECRUITING

    Aalst, 9300, Belgium

  • Novartis Investigative Site

    RECRUITING

    Ghent, 9000, Belgium

  • Novartis Investigative Site

    RECRUITING

    Wilrijk, 2610, Belgium

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 01246-000, Brazil

  • Novartis Investigative Site

    RECRUITING

    Calgary, Alberta, T2N 5G2, Canada

  • Novartis Investigative Site

    RECRUITING

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Novartis Investigative Site

    RECRUITING

    London, Ontario, N6A 4G5, Canada

  • Novartis Investigative Site

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • Novartis Investigative Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H2X 1R9, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Novartis Investigative Site

    RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100036, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, 510060, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200127, China

  • Novartis Investigative Site

    RECRUITING

    Bogota, Cundinamarca, 110111, Colombia

  • Novartis Investigative Site

    RECRUITING

    Bogotá, 110131, Colombia

  • Novartis Investigative Site

    RECRUITING

    Ostrava, Poruba, 708 52, Czechia

  • Novartis Investigative Site

    RECRUITING

    Olomouc, 779 00, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    RECRUITING

    Saint-Cloud, Hauts De Seine, 92210, France

  • Novartis Investigative Site

    RECRUITING

    Bordeaux, 33076, France

  • Novartis Investigative Site

    RECRUITING

    Bron, 69677, France

  • Novartis Investigative Site

    RECRUITING

    Clermont-Ferrand, 63011, France

  • Novartis Investigative Site

    RECRUITING

    Rouen, 76038, France

  • Novartis Investigative Site

    RECRUITING

    Saint-Herblain, 44805, France

  • Novartis Investigative Site

    RECRUITING

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    RECRUITING

    Aachen, 52074, Germany

  • Novartis Investigative Site

    RECRUITING

    Augsburg, 86179, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 10249, Germany

  • Novartis Investigative Site

    RECRUITING

    Essen, 45147, Germany

  • Novartis Investigative Site

    RECRUITING

    Münster, 48149, Germany

  • Novartis Investigative Site

    RECRUITING

    Rostock, 18057, Germany

  • Novartis Investigative Site

    RECRUITING

    Athens, 11528, Greece

  • Novartis Investigative Site

    RECRUITING

    Thessaloniki, 540 07, Greece

  • Novartis Investigative Site

    RECRUITING

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    RECRUITING

    Budapest, 1083, Hungary

  • Novartis Investigative Site

    RECRUITING

    Budapest, 1122, Hungary

  • Novartis Investigative Site

    RECRUITING

    Beersheba, 8457108, Israel

  • Novartis Investigative Site

    RECRUITING

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    RECRUITING

    Jerusalem, 9112001, Israel

  • Novartis Investigative Site

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Novartis Investigative Site

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    WITHDRAWN

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    RECRUITING

    Cona, FE, 44124, Italy

  • Novartis Investigative Site

    RECRUITING

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20141, Italy

  • Novartis Investigative Site

    RECRUITING

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    RECRUITING

    Pisa, PI, 56126, Italy

  • Novartis Investigative Site

    RECRUITING

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    RECRUITING

    Negrar, VR, 37024, Italy

  • Novartis Investigative Site

    RECRUITING

    Kashiwa, Chiba, 2778577, Japan

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 0608648, Japan

  • Novartis Investigative Site

    RECRUITING

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    RECRUITING

    Yokohama, Kanagawa, 2360004, Japan

  • Novartis Investigative Site

    RECRUITING

    Chuo Ku, Tokyo, 1040045, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 8110213, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 8120033, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukushima, 9601295, Japan

  • Novartis Investigative Site

    RECRUITING

    Ishikawa, 9208641, Japan

  • Novartis Investigative Site

    RECRUITING

    Kyoto, 6068507, Japan

  • Novartis Investigative Site

    RECRUITING

    Petaling Jaya, Selangor, 46050, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Mexico City, Mexico City, 14050, Mexico

  • Novartis Investigative Site

    RECRUITING

    Huxquilucan, 52763, Mexico

  • Novartis Investigative Site

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    RECRUITING

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    RECRUITING

    Bratislava, 83310, Slovakia

  • Novartis Investigative Site

    RECRUITING

    Košice, 041 91, Slovakia

  • Novartis Investigative Site

    RECRUITING

    Nitra, 949 01, Slovakia

  • Novartis Investigative Site

    RECRUITING

    Trenčín, 911 01, Slovakia

  • Novartis Investigative Site

    RECRUITING

    Granada, Andalusia, 18014, Spain

  • Novartis Investigative Site

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, Catalonia, 08025, Spain

  • Novartis Investigative Site

    RECRUITING

    El Palmar, Murcia, 30120, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28040, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28041, Spain

  • Novartis Investigative Site

    RECRUITING

    Seville, 41013, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, 46010, Spain

  • Novartis Investigative Site

    RECRUITING

    Geneva, 1211, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Lucerne, 6006, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Zurich, 8063, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taipei, 103616, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taipei, 11217, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Bristol, Avon, BS2 8ED, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Guildford, Surrey, GU2 7XX, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Coventry, CV2 2DX, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, NW3 2QG, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • Oregon Urology Institute

    RECRUITING

    Springfield, Oregon, 97477, United States

  • Piedmont Healthcare

    RECRUITING

    Atlanta, Georgia, 30318, United States

  • Profound Research LLC

    WITHDRAWN

    Royal Oak, Michigan, 48073, United States

  • Rio Grande Urology

    RECRUITING

    El Paso, Texas, 79912, United States

  • Rocky Mountain Cancer Centers

    RECRUITING

    Denver, Colorado, 80218, United States

  • St Louis University

    RECRUITING

    St Louis, Missouri, 63104, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • The Cancer Institute of Alexian Brothers

    RECRUITING

    Elk Grove, Illinois, 60007, United States

  • The Urology Center PC DBA UroHealth Partners

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • UCSF

    RECRUITING

    San Francisco, California, 94115, United States

  • Unity Point Clinic

    RECRUITING

    Des Moines, Iowa, 50323, United States

  • Univ of Texas Southwest Med Center

    RECRUITING

    Dallas, Texas, 75390-9034, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Kansas Hospital

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Maryland Medical Ctr

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • VA Caribbean Healthcare System

    RECRUITING

    San Juan, 00921, Puerto Rico

  • VA Greater LA Healthcare System

    RECRUITING

    Los Angeles, California, 90073, United States

  • VA Palo Alto Health Care System

    RECRUITING

    Palo Alto, California, 94304-1207, United States

  • VA St Louis Health Care System

    WITHDRAWN

    St Louis, Missouri, 63106, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Wash U School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • William Beaumont Hospital

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Woodlands Medical Specialists

    RECRUITING

    Pensacola, Florida, 32503, United States

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