Trial Title:
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
NCT ID:
NCT05849298
Condition:
Prostatic Neoplasm
Conditions: Official terms:
Prostatic Neoplasms
Gallium 68 PSMA-11
Pluvicto
Conditions: Keywords:
Prostate-specific membrane antigen (PSMA)
Lutetium [177Lu] vipivotide tetraxetan (AAA617)
Androgen Receptor Pathway Inhibitors (ARPI)
Enzalutamide
Darolutamide
Apalutamide
Castration Resistant Prostate Cancer
Androgen Deprivation Therapy
gallium [68Ga] gozetotide (AAA517)
piflufolastat F 18
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
No cross-over allowed
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AAA617
Description:
Administration intravenously once every 6 weeks (1 cycle) for 6 cycles
Arm group label:
Arm A
Arm group label:
Arm B
Other name:
Lutetium [177Lu] vipivotide tetraxetan
Other name:
177Lu-PSMA-617
Intervention type:
Drug
Intervention name:
AAA517
Description:
Single intravenous dose of approx. 150 Megabecquerel (MBq) prior PSMA-PET scans
Arm group label:
Arm A
Arm group label:
Arm B
Other name:
68Ga-PSMA-11
Intervention type:
Drug
Intervention name:
Piflufolastat F 18
Description:
Single intravenous dose of approx. 333 Megabecquerel (MBq) prior PSMA-PET scans
Arm group label:
Arm A
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
ARPI
Description:
Enzalutamide, Darolutamide, Apalutamide as prescribed by the local investigator
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
ADT
Description:
as prescribed by the local investigator
Arm group label:
Arm A
Arm group label:
Arm B
Intervention type:
Other
Intervention name:
Best supportive care
Description:
as prescribed by the local investigator
Arm group label:
Arm A
Arm group label:
Arm B
Summary:
The purpose of this study is to evaluate the efficacy and safety of AAA617 alone
(Lutetium [177Lu] vipivotide tetraxetan) and in combination with an Androgen Receptor
Pathway Inhibitors (ARPI) in participants with PSMA-positive, castration-resistant
prostate cancer and no evidence of metastasis in conventional imaging (CI) (i.e., CT/MRI
and bone scans). Approximately 120 participants will be randomized.
Criteria for eligibility:
Criteria:
Key Inclusion criteria
- Participants must be adults ≥ 18 years of age with signed informed consent prior to
participation to study
- Histologically or cytologically confirmed prostate cancer
- Participants must have ongoing androgen deprivation therapy with a GnRH
agonist/antagonist or prior bilateral orchiectomy
- Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on GnRH agonist or
antagonist therapy or after bilateral orchiectomy
- Participants must have evidence of PSMA-positive disease 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.
- PSA Doubling Time (PSADT) of ≤ 10 months
- Participants must have adequate organ functions: bone marrow reserve, hepatic &
renal
Key Exclusion criteria
- Prior or present evidence of metastatic disease as assessed by CT/MRI locally for
soft tissue disease and whole-body radionuclide bone scan for bone disease.
Exception: Participants with soft tissue pelvic disease may be eligible (e.g.,
participants with enlarged lymph nodes below the aortic bifurcation (N1) are
eligible if the short axis of the largest lymph node is <20 mm)
- 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); CYP17 inhibitors (e.g., abiraterone acetate,
orteronel, galeterone, ketoconazole; radiopharmaceutical agents (e.g.,
Strontium-89), 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
Other protocol-defined inclusion/exclusion criteria may apply.
Gender:
Male
Gender based:
Yes
Gender description:
Prostate cancer study
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Urology Cancer Center PC
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stephanie Vaughn
Phone:
402-697-2229
Email:
stephaniev@xcancer.com
Investigator:
Last name:
Luke Nordquist
Email:
Principal Investigator
Facility:
Name:
Oregon Urology Institute Research
Address:
City:
Springfield
Zip:
97477
Country:
United States
Status:
Recruiting
Contact:
Last name:
Victoria Evans
Email:
vevans@oregonurology.com
Investigator:
Last name:
Bryan Mehlhaff
Email:
Principal Investigator
Facility:
Name:
Carolina Urologic Research Center, LLC
Address:
City:
Myrtle Beach
Zip:
29572
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katie Valipour
Phone:
843-839-1679
Email:
kvalipour@curcmb.com
Investigator:
Last name:
Neal D Shore
Email:
Principal Investigator
Facility:
Name:
Urology Clinic of North Texas
Address:
City:
Dallas
Zip:
75231
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexia Demitsas
Phone:
214-271-9971
Email:
ademitsas@urologyclinics.com
Investigator:
Last name:
Wilson Hernandez
Email:
Principal Investigator
Facility:
Name:
Univ of Texas Southwest Med Center Cardiovasc And Thoracic Surg
Address:
City:
Dallas
Zip:
75390-9034
Country:
United States
Status:
Recruiting
Contact:
Last name:
Victoria Reid
Phone:
214-645-7728
Email:
Victoria.reid@ustouthwestern.edu
Investigator:
Last name:
Nghi Nguyen
Email:
Principal Investigator
Facility:
Name:
Houston Methodist Hospital Research
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vivian MacDonnell
Email:
vmmacdonnell@houstonmethodist.org
Investigator:
Last name:
Brian Miles
Email:
Principal Investigator
Facility:
Name:
Novartis Investigative Site
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Montreal
Zip:
H2X0A9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Beijing
Zip:
100028
Country:
China
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Nanjing
Zip:
210036
Country:
China
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Olomouc
Zip:
779 00
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Angers 02
Zip:
49055
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Caen
Zip:
14021
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Strasbourg
Zip:
67200
Country:
France
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Arnhem
Zip:
6815 AD
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kielce
Zip:
25-640
Country:
Poland
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Krakow
Zip:
31-501
Country:
Poland
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Singapore
Zip:
119228
Country:
Singapore
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Singapore
Zip:
169608
Country:
Singapore
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Granada
Zip:
18014
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Hospitalet de Llobregat
Zip:
08907
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Vigo
Zip:
36204
Country:
Spain
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Start date:
January 3, 2024
Completion date:
December 22, 2028
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05849298
