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RECRUITING Phase 3 ClinicalTrials.gov

An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT05939414

Registry updated: 2026-10-21
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Description

The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).

Interventions

  • AAA617 (Drug)
    Radiopharmaceutical solution for infusion/injection
  • piflufolastat (18F) (Drug)
    Provided as ready-to-use radiopharmaceutical
  • gallium (68Ga) gozetotide (25μg) (Drug)
    Provided as PSMA-11 Kit for radiopharmaceutical preparation of gallium (68Ga) gozetotide

Eligibility criteria

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.

Conditions

Oligometastatic Prostate Cancer (OMPC)

Locations

  • Highlands Oncology Group — Fayetteville, Arkansas, United States
  • VA Greater LA Healthcare System — Los Angeles, California, United States
  • VA Palo Alto Health Care System — Palo Alto, California, United States
  • Stanford University — Palo Alto, California, United States
  • UCSF — San Francisco, California, United States
  • Rocky Mountain Cancer Centers — Denver, Colorado, United States
  • Cancer Specialists of North Florida — Jacksonville, Florida, United States
  • Woodlands Medical Specialists — Pensacola, Florida, United States
  • Piedmont Healthcare — Atlanta, Georgia, United States
  • University of Chicago — Chicago, Illinois, United States
  • The Cancer Institute of Alexian Brothers — Elk Grove, Illinois, United States
  • Unity Point Clinic — Des Moines, Iowa, United States
  • University of Kansas Hospital — Kansas City, Kansas, United States
  • Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States
  • East Jefferson Hospital — Metairie, Louisiana, United States
  • University of Maryland Medical Ctr — Baltimore, Maryland, United States
  • Johns Hopkins Kimmel Com Cancer Ctr — Baltimore, Maryland, United States
  • Dana Farber Cancer Institute — Boston, Massachusetts, United States
  • Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
  • BAMF Health — Grand Rapids, Michigan, United States
  • Profound Research LLC — Royal Oak, Michigan, United States
  • William Beaumont Hospital — Royal Oak, Michigan, United States
  • Mayo Clinic Rochester — Rochester, Minnesota, United States
  • St Louis University — St Louis, Missouri, United States
  • VA St Louis Health Care System — St Louis, Missouri, United States
  • Wash U School of Medicine — St Louis, Missouri, United States
  • The Urology Center PC DBA UroHealth Partners — Omaha, Nebraska, United States
  • Memorial Sloan Kettering Cancer Ctr — New York, New York, United States
  • Associated Med Professionals of NY — Syracuse, New York, United States
  • Montefiore Hospital — The Bronx, New York, United States
  • East Carolina University — Greenville, North Carolina, United States
  • Dayton Physicians — Kettering, Ohio, United States
  • Oregon Urology Institute — Springfield, Oregon, United States
  • Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
  • Vanderbilt University Medical Center — Nashville, Tennessee, United States
  • Univ of Texas Southwest Med Center — Dallas, Texas, United States
  • Rio Grande Urology — El Paso, Texas, United States
  • Virginia Oncology Associates — Norfolk, Virginia, United States
  • Blue Ridge Cancer Center — Wytheville, Virginia, United States
  • Novartis Investigative Site — CABA, Buenos Aires, Argentina
  • Novartis Investigative Site — CABA, Argentina
  • Novartis Investigative Site — Caba, Argentina
  • Novartis Investigative Site — Darlinghurst, New South Wales, Australia
  • Novartis Investigative Site — Herston, Queensland, Australia
  • Novartis Investigative Site — Adelaide, South Australia, Australia
  • Novartis Investigative Site — Malvern, Victoria, Australia
  • Novartis Investigative Site — Linz, Austria
  • Novartis Investigative Site — Vienna, Austria
  • Novartis Investigative Site — Aalst, Belgium
  • Novartis Investigative Site — Ghent, Belgium
  • Novartis Investigative Site — Wilrijk, Belgium
  • Novartis Investigative Site — São Paulo, São Paulo, Brazil
  • Novartis Investigative Site — Calgary, Alberta, Canada
  • Novartis Investigative Site — Halifax, Nova Scotia, Canada
  • Novartis Investigative Site — London, Ontario, Canada
  • Novartis Investigative Site — Ottawa, Ontario, Canada
  • Novartis Investigative Site — Toronto, Ontario, Canada
  • Novartis Investigative Site — Montreal, Quebec, Canada
  • Novartis Investigative Site — Montreal, Quebec, Canada
  • Novartis Investigative Site — Québec, Quebec, Canada
  • Novartis Investigative Site — Beijing, China
  • Novartis Investigative Site — Guangzhou, China
  • Novartis Investigative Site — Shanghai, China
  • Novartis Investigative Site — Bogota, Cundinamarca, Colombia
  • Novartis Investigative Site — Bogotá, Colombia
  • Novartis Investigative Site — Ostrava, Poruba, Czechia
  • Novartis Investigative Site — Olomouc, Czechia
  • Novartis Investigative Site — Prague, Czechia
  • Novartis Investigative Site — Saint-Cloud, Hauts De Seine, France
  • Novartis Investigative Site — Bordeaux, France
  • Novartis Investigative Site — Bron, France
  • Novartis Investigative Site — Clermont-Ferrand, France
  • Novartis Investigative Site — Rouen, France
  • Novartis Investigative Site — Saint-Herblain, France
  • Novartis Investigative Site — Munich, Bavaria, Germany
  • Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany
  • Novartis Investigative Site — Aachen, Germany
  • Novartis Investigative Site — Augsburg, Germany
  • Novartis Investigative Site — Berlin, Germany
  • Novartis Investigative Site — Essen, Germany
  • Novartis Investigative Site — Münster, Germany
  • Novartis Investigative Site — Rostock, Germany
  • Novartis Investigative Site — Athens, Greece
  • Novartis Investigative Site — Thessaloniki, Greece
  • Novartis Investigative Site — Debrecen, Hajdu Bihar Megye, Hungary
  • Novartis Investigative Site — Budapest, Hungary
  • Novartis Investigative Site — Budapest, Hungary
  • Novartis Investigative Site — Beersheba, Israel
  • Novartis Investigative Site — Haifa, Israel
  • Novartis Investigative Site — Jerusalem, Israel
  • Novartis Investigative Site — Petah Tikva, Israel
  • Novartis Investigative Site — Tel Aviv, Israel
  • Novartis Investigative Site — Brescia, BS, Italy
  • Novartis Investigative Site — Cona, FE, Italy
  • Novartis Investigative Site — Genova, GE, Italy
  • Novartis Investigative Site — Milan, MI, Italy
  • Novartis Investigative Site — Rozzano, MI, Italy
  • Novartis Investigative Site — Pisa, PI, Italy
  • Novartis Investigative Site — Roma, RM, Italy
  • Novartis Investigative Site — Negrar, VR, Italy
  • Novartis Investigative Site — Kashiwa, Chiba, Japan
  • Novartis Investigative Site — Sapporo, Hokkaido, Japan
  • Novartis Investigative Site — Kobe, Hyōgo, Japan
  • Novartis Investigative Site — Yokohama, Kanagawa, Japan
  • Novartis Investigative Site — Chuo Ku, Tokyo, Japan
  • Novartis Investigative Site — Fukuoka, Japan
  • Novartis Investigative Site — Fukuoka, Japan
  • Novartis Investigative Site — Fukuoka, Japan
  • Novartis Investigative Site — Fukushima, Japan
  • Novartis Investigative Site — Ishikawa, Japan
  • Novartis Investigative Site — Kyoto, Japan
  • Novartis Investigative Site — Petaling Jaya, Selangor, Malaysia
  • Novartis Investigative Site — Kuala Lumpur, Malaysia
  • Novartis Investigative Site — Mexico City, Mexico City, Mexico
  • Novartis Investigative Site — Huxquilucan, Mexico
  • Novartis Investigative Site — Amsterdam, Netherlands
  • VA Caribbean Healthcare System — San Juan, Puerto Rico
  • Novartis Investigative Site — Singapore, Singapore
  • Novartis Investigative Site — Singapore, Singapore
  • Novartis Investigative Site — Bratislava, Slovakia
  • Novartis Investigative Site — Košice, Slovakia
  • Novartis Investigative Site — Nitra, Slovakia
  • Novartis Investigative Site — Trenčín, Slovakia
  • Novartis Investigative Site — Granada, Andalusia, Spain
  • Novartis Investigative Site — L'Hospitalet de Llobregat, Barcelona, Spain
  • Novartis Investigative Site — Barcelona, Catalonia, Spain
  • Novartis Investigative Site — El Palmar, Murcia, Spain
  • Novartis Investigative Site — Barcelona, Spain
  • Novartis Investigative Site — Madrid, Spain
  • Novartis Investigative Site — Madrid, Spain
  • Novartis Investigative Site — Seville, Spain
  • Novartis Investigative Site — Valencia, Spain
  • Novartis Investigative Site — Geneva, Switzerland
  • Novartis Investigative Site — Lucerne, Switzerland
  • Novartis Investigative Site — Zurich, Switzerland
  • Novartis Investigative Site — Taipei, Taiwan
  • Novartis Investigative Site — Taipei, Taiwan
  • Novartis Investigative Site — Taipei, Taiwan
  • Novartis Investigative Site — Taoyuan, Taiwan
  • Novartis Investigative Site — Bristol, Avon, United Kingdom
  • Novartis Investigative Site — Guildford, Surrey, United Kingdom
  • Novartis Investigative Site — Coventry, United Kingdom
  • Novartis Investigative Site — London, United Kingdom
  • Novartis Investigative Site — London, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record