An International, Prospective, Open-label, Multi-center, Randomized Phase III Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) Versus Observation to Delay Castration or Disease Recurrence in Adult Male Patients With Prostate-specific Membrane Antigen (PSMA) Positive Oligometastatic Prostate Cancer (OMPC)

Status: Recruiting
Location: See all (124) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Histologically confirmed prostate cancer prior to randomization

• 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))

• 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)

• 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

• 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.

• All metastatic lesions detected at screening must be amenable to SBRT

• Non-castration testosterone level \>100 ng/dL at screening

Locations
United States
Arkansas
Highlands Oncology Group
RECRUITING
Fayetteville
California
VA Greater LA Healthcare System
RECRUITING
Los Angeles
Stanford University
RECRUITING
Palo Alto
VA Palo Alto Health Care System
RECRUITING
Palo Alto
UCSF
RECRUITING
San Francisco
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Denver
Florida
Cancer Specialists of North Florida
RECRUITING
Jacksonville
Woodlands Medical Specialists
RECRUITING
Pensacola
Georgia
Piedmont Healthcare
RECRUITING
Atlanta
Illinois
University of Chicago
RECRUITING
Chicago
The Cancer Institute of Alexian Brothers
RECRUITING
Elk Grove
Kansas
University of Kansas Hospital
RECRUITING
Kansas City
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Maryland
Johns Hopkins Kimmel Com Cancer Ctr
RECRUITING
Baltimore
University of Maryland Medical Ctr
RECRUITING
Baltimore
Michigan
BAMF Health
RECRUITING
Grand Rapids
Profound Research LLC
RECRUITING
Royal Oak
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Missouri
VA St Louis Health Care System
RECRUITING
St Louis
Wash U School of Medicine
RECRUITING
St Louis
North Carolina
East Carolina University
RECRUITING
Greenville
Nebraska
Adult and Pedi Urology and Urogyne
RECRUITING
Omaha
New York
Memorial Sloane Ketterin Cancer Ctr
RECRUITING
New York
Associated Med Professionals of NY
RECRUITING
Syracuse
Ohio
Dayton Physicians
RECRUITING
Kettering
Oregon
Oregon Urology Institute
RECRUITING
Springfield
South Carolina
Carolina Urologic Research Center
RECRUITING
Myrtle Beach
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Univ of Texas Southwest Med Center
RECRUITING
Dallas
Rio Grande Urology
RECRUITING
El Paso
Virginia
Virginia Oncology Associates
RECRUITING
Norfolk
Blue Ridge Cancer Center
RECRUITING
Wytheville
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Caba
Australia
Novartis Investigative Site
RECRUITING
Adelaide
Novartis Investigative Site
RECRUITING
Darlinghurst
Novartis Investigative Site
RECRUITING
Herston
Novartis Investigative Site
RECRUITING
Malvern
Austria
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Linz
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Vienna
Belgium
Novartis Investigative Site
RECRUITING
Aalst
Novartis Investigative Site
RECRUITING
Ghent
Novartis Investigative Site
RECRUITING
Wilrijk
Brazil
Novartis Investigative Site
RECRUITING
São Paulo
Canada
Novartis Investigative Site
RECRUITING
Calgary
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Ottawa
Novartis Investigative Site
RECRUITING
Québec
Novartis Investigative Site
RECRUITING
Toronto
China
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Shanghai
France
Novartis Investigative Site
RECRUITING
Bordeaux
Novartis Investigative Site
RECRUITING
Bron
Novartis Investigative Site
RECRUITING
Clermont-ferrand
Novartis Investigative Site
RECRUITING
Rouen
Novartis Investigative Site
RECRUITING
Saint-cloud
Novartis Investigative Site
RECRUITING
Saint-herblain
Germany
Novartis Investigative Site
RECRUITING
Aachen
Novartis Investigative Site
RECRUITING
Augsburg
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Cologne
Novartis Investigative Site
RECRUITING
Essen
Novartis Investigative Site
RECRUITING
Rostock
Greece
Novartis Investigative Site
RECRUITING
Thessaloniki
Hungary
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Budapest
Novartis Investigative Site
RECRUITING
Debrecen
Israel
Novartis Investigative Site
RECRUITING
Beersheba
Novartis Investigative Site
RECRUITING
Haifa
Novartis Investigative Site
RECRUITING
Jerusalem
Novartis Investigative Site
RECRUITING
Petah Tikva
Novartis Investigative Site
RECRUITING
Tel Aviv
Italy
Novartis Investigative Site
RECRUITING
Brescia
Novartis Investigative Site
RECRUITING
Cona
Novartis Investigative Site
RECRUITING
Genova
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
RECRUITING
Negrar
Novartis Investigative Site
RECRUITING
Pisa
Novartis Investigative Site
RECRUITING
Roma
Novartis Investigative Site
RECRUITING
Rozzano
Japan
Novartis Investigative Site
RECRUITING
Chuo Ku
Novartis Investigative Site
RECRUITING
Fukuoka
Novartis Investigative Site
RECRUITING
Fukuoka
Novartis Investigative Site
RECRUITING
Fukuoka
Novartis Investigative Site
RECRUITING
Fukushima
Novartis Investigative Site
RECRUITING
Kanazawa
Novartis Investigative Site
RECRUITING
Kashiwa
Novartis Investigative Site
RECRUITING
Kobe
Novartis Investigative Site
RECRUITING
Kyoto
Novartis Investigative Site
RECRUITING
Sapporo
Novartis Investigative Site
RECRUITING
Yokohama
Malaysia
Novartis Investigative Site
RECRUITING
Kuala Lumpur
Novartis Investigative Site
RECRUITING
Petaling Jaya
Netherlands
Novartis Investigative Site
RECRUITING
Amsterdam
Puerto Rico
VA Caribbean Healthcare System
RECRUITING
San Juan
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Slovakia
Novartis Investigative Site
RECRUITING
Bratislava
Novartis Investigative Site
RECRUITING
Nitra
Novartis Investigative Site
RECRUITING
Trenčín
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
El Palmar
Novartis Investigative Site
RECRUITING
Granada
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Seville
Novartis Investigative Site
RECRUITING
Valencia
Switzerland
Novartis Investigative Site
RECRUITING
Geneva
Novartis Investigative Site
RECRUITING
Lucerne
Novartis Investigative Site
RECRUITING
Zurich
Taiwan
Novartis Investigative Site
RECRUITING
Taipei
Novartis Investigative Site
RECRUITING
Taipei
Novartis Investigative Site
RECRUITING
Taipei
Novartis Investigative Site
RECRUITING
Taoyuan District
United Kingdom
Novartis Investigative Site
RECRUITING
Bristol
Novartis Investigative Site
RECRUITING
Coventry
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Sutton
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Time Frame
Start Date: 2024-03-12
Estimated Completion Date: 2031-10-03
Participants
Target number of participants: 450
Treatments
Experimental: Investigational Arm: lutetium (177Lu) vipivotide tetraxetan (AAA617)
All participants will be treated with Stereotactic Body Radiation Therapy (SBRT) to all metastatic lesions followed by a dose of 7.4 GBq (200 mCi) +/- 10% of AAA617 which will be administered once every 6 weeks (1 cycle) for a planned 4 cycles.
No_intervention: Control arm: observation (watchful waiting)
All participants will be treated with Stereotactic Body Radiation Therapy (SBRT) to all metastatic lesions followed by observation only.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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