A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
- Conditions
- Prostatic Neoplasm
- Interventions
- Registration Number
- NCT05849298
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A AAA617 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. Arm A AAA517 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. Arm A ADT 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. Arm B Piflufolastat F 18 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. Arm A Piflufolastat F 18 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. Arm A Best supportive care 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. Arm B AAA617 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. Arm B ARPI 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. Arm B AAA517 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. Arm B Best supportive care 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. Arm B ADT 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.
- Primary Outcome Measures
Name Time Method PSA response From randomization until PSA nadir value of =< 0.2 ng/mL that is confirmed by a second (the next) PSA measurement >= 4 weeks later, up to 5 years PSA response is defined as the time of PSA nadir value of =\< 0.2 ng/mL is confirmed by a second (the next) PSA measurement at least 4 weeks later
- Secondary Outcome Measures
Name Time Method Time to initiation of cytotoxic chemotherapy From the date of randomization to the date of first documented dose of new cytotoxic chemotherapy administered to the participant, up to 5 years Time to initiation of cytotoxic chemotherapy will be defined as the time from the date of randomization to the date of first documented dose of new cytotoxic chemotherapy being administered to the participant
Time to distant metastasis development From the date of randomization to the date of first evidence of radiographically detectable bone or soft tissue distant metastasis, up to 5 years Time to distant metastasis development is defined as the time from the date of randomization to the date of first evidence of radiographically detectable bone or soft tissue distant metastasis by conventional imaging using RECIST 1.1
Time to local radiological progression From the date of randomization to the date of first documented local radiographic disease progression, up to 5 years Time to local radiological progression is defined as the time from the date of randomization to the date of first documented local radiographic disease progression by conventional imaging using RECIST 1.1
Time to initiation or change in therapy From the date of randomization to the date of first dose of a new / change in therapy, up to 5 years Time to initiation or change in therapy is defined as the time from the date of randomization to the date of first documented dose of a new / change in therapy being administered to the participant
Time to PSA response From randomization to PSA response, up to 5 years Time to PSA response is calculated as the time from randomization to PSA response with a PSA nadir value of =\< 0.2ng/mL.
Radiographic Progression Free Survival (rPFS) From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, up to 5 years rPFS is defined as the time from the date of randomization to the date of first documented radiographic disease progression by conventional imaging assessed using RECIST 1.1 or death.
Metastatic Free Survival (MFS) From date of randomization until date of progression or date of death whichever occurs first, up to 5 years MFS is defined as the time from date of randomization to the first evidence of radiographically detectable bone or soft tissue distant metastasis by conventional imaging using RECIST 1.1 or death.
Overall Survival (OS) From date of randomization until date of death from any cause, up to 5 years OS defined as date of death due to any cause
Time to first symptomatic skeletal event (TTSSE) From the date of randomization to the date of the first new symptomatic pathological bone fracture, spinal cord compression, orthopedic surgical intervention, radiation therapy or death due to any cause, whichever occurs first, up to 5 years TTSSE is defined as the time from the date of randomization to the first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death due to any cause, whichever occurs first
PSA90 response From date of randomization until end of efficacy follow-up, up to 5 years PSA90 response is defined as the proportion of participants who have a \>= 90% decrease in PSA from baseline that is confirmed by a second (the next) PSA measurement \>= 4 weeks later
second Progression Free Survival (PFS2) From date of randomization until date of second progression or date of death from any cause, whichever comes first, assessed up to 5 years PFS2 defined as time from the date of randomization to the date of first documented disease progression by investigator's assessment (PSA, radiographic, symptomatic, or any combination) on next line of therapy subsequent to MFS event or death due to any cause, whichever occurs first
Time to symptomatic progression From date of randomization until development of a symptomatic skeletal event, new systemic anti-cancer therapy, surgical intervention or radiation therapy, whichever occurs first, up to 5 years Time to symptomatic progression will be defined as the time from the date of randomization to the date of first documented event for any of the following:
* Development of a symptomatic skeletal event (SSE)
* Pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy
* Development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapyPSA50 response From date of randomization until end of efficacy follow-up, up to 5 years PSA50 response is defined as the proportion of participants who have a \>= 50% decrease in PSA from baseline that is confirmed by a second (the next) PSA measurement \>= 4 weeks later
Functional Assessment of Cancer Therapy - Prostate (FACT-P) From date of randomization until end of efficacy follow-up, up to 5 years FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACTGeneral (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.
Functional Assessment of Cancer Therapy - Radiotherapies (FACT-RNT) Questionnaire From date of randomization until end of efficacy follow-up, up to 5 years The FACT-RNT is assessing treatment-related symptoms of special interest/associated with Radionuclides Therapies. The FACT-RNT contains 15 items assessing dry mouth, dry eyes, difficulty urinating, nausea, vomiting, diarrhea, constipation, loss of appetite, fatigue, impact of fatigue, pain, bone pain, pain interference, bothered by of side effects of treatment and isolation due to illness or treatment.
Brief Pain Inventory - Short Form (BPI-SF) Questionnaire From date of randomization until end of efficacy follow-up, up to 5 years The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item selfreport questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 \[no pain\] to 10 \[pain as bad as you can imagine\]). Pain severity progression is defined as an increase in score of 30% or greater from baseline without decrease in analgesic use.
Trial Locations
- Locations (15)
Urology Associates of Mobile
🇺🇸Mobile, Alabama, United States
Rocky Mountain Cancer Centers
🇺🇸Longmont, Colorado, United States
University Cancer and Blood Center LLC
🇺🇸Athens, Georgia, 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, LLC
🇺🇸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
🇪🇸Madrid, Spain