Prostatic NeoplasmPhase 2PSMACareNCT05849298
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC
A Phase 2 study testing AAA617, AAA517 and Piflufolastat F 18 in people with Prostatic Neoplasm, run by Novartis Pharmaceuticals at 31 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- AAA617, AAA517 and Piflufolastat F 18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 31 sitesin 11 countries
- Study dates
- 3 Jan 2024to 23 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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
Who cannot join
- 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 pelvic disease may be eligible (e.g., participants with enlarged lymph nodes below the bifurcation of common iliac arteries (N1))
- 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
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
31 sites in 11 countries.
31 sites in 11 countries
United States10 sites
University Cancer and Blood Center LLC
Athens, Georgia, 30607
Univ of Texas Southwest Med Center
Dallas, Texas, 75390-9034
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Unity Point Clinic
Des Moines, Iowa, 50323
Rio Grande Urology
El Paso, Texas, 79912
Houston Methodist Hospital
Houston, Texas, 77030
Urology Of Indiana
Indianapolis, Indiana, 46254
Urology Cancer Center PC
Omaha, Nebraska, 68130
Oregon Urology Institute
Springfield, Oregon, 97477
Wellspan York Hospital
York, Pennsylvania, 17403
Italy4 sites
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Roma, RM, 00128
Canada3 sites
Novartis Investigative Site
Montreal, Quebec, H2X 1R9
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
France3 sites
Novartis Investigative Site
Angers, 49055
Novartis Investigative Site
Brest, 29609
Novartis Investigative Site
Strasbourg, 67085
Spain3 sites
Novartis Investigative Site
Barcelona, 08036
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Madrid, 28040
Brazil2 sites
Novartis Investigative Site
São Paulo, São Paulo, 01308-050
Novartis Investigative Site
São Paulo, São Paulo, 05652-000
South Korea2 sites
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 05505
About this study
Official title: An International Prospective Open-label, Multi-center, Randomized, Non-comparative Phase II Study of Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) Alone and Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) in Combination With Androgen Receptor Pathway Inhibitors in Patients With PSMA PET Scan Positive Castration-Resistant Prostate Cancer
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).
Read the detailed description
All participants will be assessed for eligibility and will undergo baseline disease assessments including a mandatory gallium [68Ga] gozetotide (hereinafter referred to as AAA517) or piflufolastat (18F) (also known as[18F]DCFPyL) PET/CT scan and conventional imaging (i.e., CT/MRI and bone scans). Piflufolastat- (18F) PET/CT scan will be performed in US only.
The treatment duration will be up to 6 cycles of AAA617, treatment will be administered once every 6 weeks (duration of 1 cycle). Participants randomized to Arm B may continue to receive ARPI after second end of treatment (EOT2) outside the study protocol at the investigator's discretion and in accordance with local guidelines.
The visit frequency will be every week 1 and week 4 of each of the 6 cycles and every 16 weeks thereafter (for both arms) until the first event of disease progression (RECIST 1.1) or until global end of study (EOS), whichever comes first. After cycle 1 the safety visit at week 4 is optional onsite and could be paired with efficacy assessments or handled remotely. No biomarker collections are expected after the last end of trial (EOT) visit is completed. The study duration will be approximately 36 months.
- Conditions
- Prostatic Neoplasm
- Being tested
- AAA617, AAA517, Piflufolastat F 18, ARPI, ADT
- 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
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAA617Drug
Also called Lutetium [177Lu] vipivotide tetraxetan, 177Lu-PSMA-617
Administration intravenously once every 6 weeks (1 cycle) for 6 cycles
AAA517Drug
Also called 68Ga-PSMA-11
Single intravenous dose of approx. 150 Megabecquerel (MBq) prior PSMA-PET scans
Piflufolastat F 18Drug
Single intravenous dose of approx. 333 Megabecquerel (MBq) prior PSMA-PET scans
ARPIDrug
Enzalutamide, Darolutamide, Apalutamide as prescribed by the local investigator
ADTDrug
as prescribed by the local investigator
Best supportive careOther
as prescribed by the local investigator
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 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. Receives: Drug: AAA617; Drug: AAA517; Drug: Piflufolastat F 18; Drug: ADT; Other: Best supportive care |
| Arm B | Experimental | 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. Receives: Drug: AAA617; Drug: AAA517; Drug: Piflufolastat F 18; Drug: ARPI; Drug: ADT; Other: Best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA response
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
Measured: 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
Secondary outcomes (16)
Metastatic Free Survival (MFS)
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.
Measured: From date of randomization until date of progression or date of death whichever occurs first, up to 5 years
Radiographic Progression Free Survival (rPFS)
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.
Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, up to 5 years
Overall Survival (OS)
OS defined as date of death due to any cause
Measured: From date of randomization until date of death from any cause, up to 5 years
second Progression Free Survival (PFS2)
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
Measured: From date of randomization until date of second progression or date of death from any cause, whichever comes first, assessed up to 5 years
Time to symptomatic progression
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 therapy
Measured: 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 initiation of cytotoxic chemotherapy
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
Measured: 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 first symptomatic skeletal event (TTSSE)
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
Measured: 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
Time to distant metastasis development
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
Measured: 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 local radiological progression
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
Measured: From the date of randomization to the date of first documented local radiographic disease progression, up to 5 years
Time to initiation or change in therapy
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
Measured: From the date of randomization to the date of first dose of a new / change in therapy, up to 5 years
Time to PSA response
Time to PSA response is calculated as the time from randomization to PSA response with a PSA nadir value of =< 0.2ng/mL.
Measured: From randomization to PSA response, up to 5 years
PSA50 response
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
Measured: From date of randomization until end of efficacy follow-up, up to 5 years
PSA90 response
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
Measured: From date of randomization until end of efficacy follow-up, up to 5 years
Functional Assessment of Cancer Therapy - Prostate (FACT-P)
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.
Measured: From date of randomization until end of efficacy follow-up, up to 5 years
Functional Assessment of Cancer Therapy - Radiotherapies (FACT-RNT) Questionnaire
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.
Measured: From date of randomization until end of efficacy follow-up, up to 5 years
Brief Pain Inventory - Short Form (BPI-SF) Questionnaire
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.
Measured: From date of randomization until end of efficacy follow-up, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start3 Jan 2024
- Primary completion23 Dec 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- No cross-over allowed
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849298
- Sponsor's protocol ID
- CAAA617B12203
- Other IDs
- 2022-503040-41-00
- Acronym
- PSMACare
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Prospective Open-label, Multi-center, Randomized, Non-comparative Phase II Study of Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) Alone and Lutetium [177Lu] Vipivotide Tetraxetan (AAA617) in Combination With Androgen Receptor Pathway Inhibitors in Patients With PSMA PET Scan Positive Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT05849298
- Acronym / sponsor ID
- PSMACare / CAAA617B12203
- Conditions
- Prostatic Neoplasm
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 23 Dec 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
All participants will be assessed for eligibility and will undergo baseline disease assessments including a mandatory gallium [68Ga] gozetotide (hereinafter referred to as AAA517) or piflufolastat (18F) (also known as[18F]DCFPyL) PET/CT scan and conventional imaging (i.e., CT/MRI and bone scans). Piflufolastat- (18F) PET/CT scan will be performed in US only.
The treatment duration will be up to 6 cycles of AAA617, treatment will be administered once every 6 weeks (duration of 1 cycle). Participants randomized to Arm B may continue to receive ARPI after second end of treatment (EOT2) outside the study protocol at the investigator's discretion and in accordance with local guidelines.
The visit frequency will be every week 1 and week 4 of each of the 6 cycles and every 16 weeks thereafter (for both arms) until the first event of disease progression (RECIST 1.1) or until global end of study (EOS), whichever comes first. After cycle 1 the safety visit at week 4 is optional onsite and could be paired with efficacy assessments or handled remotely. No biomarker collections are expected after the last end of trial (EOT) visit is completed. The study duration will be approximately 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- No cross-over allowed
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: AAA617, Drug: AAA517, Drug: Piflufolastat F 18, Drug: ADT, Other: Best supportive careParticipants 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 | Experimental | Drug: AAA617, Drug: AAA517, Drug: Piflufolastat F 18, Drug: ARPI, Drug: ADT, Other: Best supportive careParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 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
Key exclusion criteria (6 listed)
- 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 pelvic disease may be eligible (e.g., participants with enlarged lymph nodes below the bifurcation of common iliac arteries (N1))
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAA617Also: Lutetium [177Lu] vipivotide tetraxetan, 177Lu-PSMA-617Administration intravenously once every 6 weeks (1 cycle) for 6 cycles | Drug | Arm A, Arm B |
| AAA517Also: 68Ga-PSMA-11Single intravenous dose of approx. 150 Megabecquerel (MBq) prior PSMA-PET scans | Drug | Arm A, Arm B |
| Piflufolastat F 18Single intravenous dose of approx. 333 Megabecquerel (MBq) prior PSMA-PET scans | Drug | Arm A, Arm B |
| ARPIEnzalutamide, Darolutamide, Apalutamide as prescribed by the local investigator | Drug | Arm B |
| ADTas prescribed by the local investigator | Drug | Arm A, Arm B |
| Best supportive careas prescribed by the local investigator | Other | Arm A, Arm B |
Primary outcome
PSA response
Time frame: 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
16 secondary outcomes
Metastatic Free Survival (MFS)
Time frame: From date of randomization until date of progression or date of death whichever occurs first, up to 5 years
Radiographic Progression Free Survival (rPFS)
Time frame: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, up to 5 years
Overall Survival (OS)
Time frame: From date of randomization until date of death from any cause, up to 5 years
second Progression Free Survival (PFS2)
Time frame: From date of randomization until date of second progression or date of death from any cause, whichever comes first, assessed up to 5 years
Time to symptomatic progression
Time frame: 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 initiation of cytotoxic chemotherapy
Time frame: 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 first symptomatic skeletal event (TTSSE)
Time frame: 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
Time to distant metastasis development
Time frame: 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 local radiological progression
Time frame: From the date of randomization to the date of first documented local radiographic disease progression, up to 5 years
Time to initiation or change in therapy
Time frame: From the date of randomization to the date of first dose of a new / change in therapy, up to 5 years
Time to PSA response
Time frame: From randomization to PSA response, up to 5 years
PSA50 response
Time frame: From date of randomization until end of efficacy follow-up, up to 5 years
PSA90 response
Time frame: From date of randomization until end of efficacy follow-up, up to 5 years
Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Time frame: From date of randomization until end of efficacy follow-up, up to 5 years
Functional Assessment of Cancer Therapy - Radiotherapies (FACT-RNT) Questionnaire
Time frame: From date of randomization until end of efficacy follow-up, up to 5 years
Brief Pain Inventory - Short Form (BPI-SF) Questionnaire
Time frame: From date of randomization until end of efficacy follow-up, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Related trials for Prostatic Neoplasm
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
31 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AAA617, AAA517 and Piflufolastat F 18 in people with Prostatic Neoplasm, run by Novartis Pharmaceuticals at 31 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Italy, Canada, France, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA response (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.