A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
NCT ID: NCT05849298
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2024-01-03
2030-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Participants will receive 7.4 GBq (+/- 10%) of AAA617 (Lutetium \[177Lu\] vipivotide tetraxetan) once every 6 weeks for 6 cycles. ADT must be ongoing; Best supportive care is allowed.
AAA617
Administration intravenously once every 6 weeks (1 cycle) for 6 cycles
AAA517
Single intravenous dose of approx. 150 Megabecquerel (MBq) prior PSMA-PET scans
Piflufolastat F 18
Single intravenous dose of approx. 333 Megabecquerel (MBq) prior PSMA-PET scans
ADT
as prescribed by the local investigator
Best supportive care
as prescribed by the local investigator
Arm B
Participants will receive 7.4 GBq (+/- 10%) of AAA617 (Lutetium \[177Lu\] vipivotide tetraxetan) once every 6 weeks for 6 cycles. In addition of SOC (ADT plus choice of ARPI as per physician's decision), Best supportive care is allowed.
AAA617
Administration intravenously once every 6 weeks (1 cycle) for 6 cycles
AAA517
Single intravenous dose of approx. 150 Megabecquerel (MBq) prior PSMA-PET scans
Piflufolastat F 18
Single intravenous dose of approx. 333 Megabecquerel (MBq) prior PSMA-PET scans
ARPI
Enzalutamide, Darolutamide, Apalutamide as prescribed by the local investigator
ADT
as prescribed by the local investigator
Best supportive care
as prescribed by the local investigator
Interventions
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AAA617
Administration intravenously once every 6 weeks (1 cycle) for 6 cycles
AAA517
Single intravenous dose of approx. 150 Megabecquerel (MBq) prior PSMA-PET scans
Piflufolastat F 18
Single intravenous dose of approx. 333 Megabecquerel (MBq) prior PSMA-PET scans
ARPI
Enzalutamide, Darolutamide, Apalutamide as prescribed by the local investigator
ADT
as prescribed by the local investigator
Best supportive care
as prescribed by the local investigator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed prostate cancer
* Participants must have ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy at the time of randomization. Intermittent administration of ADT is accepted before randomization if criterion for serum testosterone is met
* Castrate level of serum testosterone (\< 1.7 nmol/l \[50 ng/dl\]) on GnRH agonist or antagonist therapy (continuous/intermittent) or after bilateral orchiectomy prior to randomization
* Participants must have evidence of PSMA-positive disease (N1 or M1) as seen on a AAA517 or piflufolastat F 18 PET/CT scan at baseline as determined by Blinded Independent Central Review (BICR) based on the methodology proposed in the Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) (Eiber et al 2018). Participants with M1 disease only on PSMA PET scan are allowed to participate
* Participants must have a negative conventional imaging for M1 disease.
* Participants must have adequate organ functions: bone marrow reserve, hepatic \& renal
Exclusion Criteria
* Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable with best available standard of care (incl. pads, drainage) are allowed
* Active clinically significant cardiac disease; history of seizure or condition that may pre-dispose to seizure which may require treatment with surgery or radiation therapy
* Prior therapy with: second generation anti-androgens (e.g., enzalutamide, apalutamide and darolutamide) \< 3 months before randomization; CYP17 inhibitors (e.g., abiraterone acetate, orteronel, galeterone) \< 3 months before randomization; ketoconazole (short duration ketoconazole treatment (\<28 days) is permitted); radiopharmaceutical agents (e.g., Strontium-89) if wash-out period of at least 3 months is not completed, PSMA-targeted radioligand therapy; immunotherapy (e.g., sipuleucel-T); chemotherapy, except if administered in the adjuvant/neoadjuvant setting, completed \> 2 years before randomization; any other investigational agents for CRPC; use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethimide) or first-generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) within 28 days before randomization; radiation therapy (external beam radiation therapy \[EBRT\] and brachytherapy within 28 days before randomization
* Other concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, biological therapy or investigational therapy
18 Years
100 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Urology Associates of Mobile
Mobile, Alabama, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
University Of Florida
Jacksonville, Florida, United States
University Cancer and Blood Center LLC
Athens, Georgia, United States
Urology Of Indiana
Indianapolis, Indiana, United States
Unity Point Clinic
Des Moines, Iowa, United States
Urology Cancer Center PC
Omaha, Nebraska, United States
Associated Med Professionals of NY
Syracuse, New York, United States
Oregon Urology Institute
Springfield, Oregon, United States
Wellspan York Hospital
York, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Clinic of North Texas
Dallas, Texas, United States
Univ of Texas Southwest Med Center
Dallas, Texas, United States
Rio Grande Urology
El Paso, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
UT Health San Antonio Mays Cancer Center
San Antonio, Texas, United States
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Halifax, Nova Scotia, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Nanjing, Jiangsu, China
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Beijing, , China
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Olomouc, , Czechia
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Angers, , France
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Brest, , France
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Caen, , France
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Paris, , France
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Strasbourg, , France
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Cologne, North Rhine-Westphalia, Germany
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Berlin, , Germany
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Rostock, , Germany
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Genova, GE, Italy
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Milan, MI, Italy
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Roma, RM, Italy
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Napoli, , Italy
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Arnhem, Gelderland, Netherlands
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Kielce, , Poland
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Krakow, , Poland
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Singapore, , Singapore
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Singapore, , Singapore
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Seoul, , South Korea
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Seoul, , South Korea
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Granada, Andalusia, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Terrassa, Catalonia, Spain
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Vigo, Pontevedra, Spain
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Barcelona, , Spain
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Madrid, , Spain
Novartis Investigative Site
Valencia, , Spain
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Facility Contacts
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Other Identifiers
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2022-503040-41-00
Identifier Type: OTHER
Identifier Source: secondary_id
CAAA617B12203
Identifier Type: -
Identifier Source: org_study_id
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