A Phase 3 interventional study of AAA617 and piflufolastat (18F) in Oligometastatic Prostate Cancer (OMPC), sponsored by Novartis Pharmaceuticals. Recruiting at 144 sites in 27 countries. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 41 studies testing lutetium (¹⁷⁷Lu) vipivotide tetraxetan in Prostatic Neoplasms — 21 open to participants now, 31 under way, 2 of them phase 3. lutetium (¹⁷⁷Lu) vipivotide tetraxetan · Prostatic Neoplasms.
Among the 41 studies testing lutetium (¹⁷⁷Lu) vipivotide tetraxetan in Prostatic Neoplasms, this one is the 6th largest by planned enrollment, is one of 8 that started in 2024, is one of 4 in phase 3, reaches primary completion later than 22 of the 30 other live ones, and was the 21st registered.
7,047 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →21 of the 41 studies testing lutetium (¹⁷⁷Lu) vipivotide tetraxetan in Prostatic Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
University of Washington · Sites in United States
Ages 18+ · Men only
Mayo Clinic · Sites in United States
Ages 18+ · Men only
University of California, San Francisco · Sites in United States
Ages 18+ · Men only
Jean-Mathieu Beauregard · Sites in Canada
Ages 18+ · Men only
Case Comprehensive Cancer Center · Sites in United States
Ages 19+
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years to 100 Years · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 26 · Phase 3 4 · Phase 4 2
First in 2016; this study’s year is marked. 8 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 450 is above the median of 60 across 5,349 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 49 across the 41 interventional studies. Of the 9 that completed or were terminated, 6 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 41 have an industry lead sponsor. The 10 most frequent:
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
82 studies in Prostatic Neoplasms by Novartis: 13 open now, 26 under way, 4 of them phase 3. Of 53 finished, 11 (21%) have results posted.
Among the 82 studies in Prostatic Neoplasms by Novartis, this one is the 9th largest by planned enrollment of the 70 interventional ones that give a count, is one of 6 that started in 2024, is one of 12 in phase 3, reaches primary completion later than 12 of the 25 other live ones, and was the 59th registered.
Novartis’s Prostatic Neoplasms studies by the year they started, since 1999.
9 of the studies testing lutetium (¹⁷⁷Lu) vipivotide tetraxetan in Prostatic Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05849298Novartis PharmaceuticalsA Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC | 2026-12-23 |
| NCT06145633Fred Hutchinson Cancer CenterVorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer | 2026-12-30 |
| NCT06288113Jonsson Comprehensive Cancer CenterRe-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial | 2027-01-27 |
| NCT06972628Ebrahim S DelpassandTreatment of Patients With Progressive mCRPC With 177Lu-PSMA-617 | 2027-04-01 |
| NCT07054346Thomas HopeComparison of 177Lu-PSMA-617 and 225Ac-PSMA-617 | 2027-04-30 |
Add all 9 to your calendar (.ics) → With an account.
Among the 41 studies testing lutetium (¹⁷⁷Lu) vipivotide tetraxetan in Prostatic Neoplasms, from their registry updates:
Among Novartis’s 82 in Prostatic Neoplasms:
This tab as a report to print or save as PDF → With an account.
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).
All participants will be assessed for eligibility and will undergo baseline disease assessments including a mandatory gallium (68Ga) gozetotide (also known as [68Ga]Ga-PSMA-11) or piflufolastat (18F) ( also known as[18F]DCFPyL) PET/CT scan and CI (i.e., CT/MRI and bone scans).
Piflufolastat (18F) PET/CT scan will be performed in countries where it is approved.
Stereotactic Body Radiation Therapy (SBRT) will be administered to all metastatic Prostate Cancer (PC) lesions after randomization and before the start of treatment with AAA617 or observation.
Key Inclusion criteria:
Participants must have a negative CI for M1 disease at screening.
Note:
Key Exclusion criteria:
Prior therapy with:
ADT (including bilateral orchiectomy) and ARPIs used for metastatic prostate cancer treatment
Patients who biochemically after primary therapy may also have had treatment with AR directed therapy and participants who had SBRT with ADT are also eligible provided that the ARPI +/- ADT or ADT alone was terminated
≥12 months prior to randomization for ADT (i.e., 12 months after the last day of the last injection) or ≥3 months if ARPI was given as monotherapy.
Other hormonal therapy. e.g.,
•Use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethimide) if used in the context of prostate cancer treatment. Same medications are allowed if used for other indications: e.g., Benign Prostatic Hyperplasia (BPH), if stopped ≥3 months before randomization.
History or current diagnosis of abnormalities indicating significant risk of safety for participants participating in the study such as:
Other protocol defined Inclusion/Exclusion may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: AAA617 · Drug: piflufolastat (18F) · Drug: gallium (68Ga) gozetotide (25μg)
All participants will be treated with Stereotactic Body Radiation Therapy (SBRT) to all metastatic lesions followed by observation only.
Radiopharmaceutical solution for infusion/injection
Also known as: (177Lu) vipivotide tetraxetan
Provided as ready-to-use radiopharmaceutical
Provided as PSMA-11 Kit for radiopharmaceutical preparation of gallium (68Ga) gozetotide
Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS)
Blinded Independent Review Committee (BIRC) assessed Metastasis Free Survival (MFS) is defined as the time from randomization to first evidence of radiographically detectable bone or soft tissue distant metastasis by conventional imaging (i.e., Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) and bone scans) as assessed by BIRC using RECIST 1.1 or death due to any cause, whichever occurs first. Participants who are alive without distant metastasis at the analysis data cut-off or are lost to follow-up at the time of analysis will be censored for MFS at the time of their last adequate radiographic assessment. Clinical deterioration without objective radiographic evidence will not be considered as documented distant metastasis.
Time frame: From date of randomization until first evidence of radiographically detectable bone or soft tissue distant metastasis or death due to any cause, whichever occurs first, assessed up to approximately 30 months
Key secondary endpoint: Time to Hormonal Therapy (TTHT)
Time to Hormonal Therapy (TTHT) is defined as the time from randomization to the time to Androgen Deprivation Therapy (ADT). The type of hormonal therapy will be at the discretion of the Investigator.
Time frame: From date of randomization until date of Androgen Deprivation Therapy (ADT), assessed up to approximately 74 months
Investigator assessed Metastasis Free Survival (MFS)
Investigator assessed Metastasis Free Survival (MFS) is defined as the time from randomization to the first evidence of radiographically detectable bone or soft tissue distant metastasis by conventional imaging (i.e., CT/MRI and bone scans) as assessed by Investigator using RECIST 1.1 or death from any cause, whichever occurs first.
Time frame: From date of randomization until first evidence of radiographically detectable bone or soft tissue distant metastasis or death from any cause, whichever occurs first, assessed up to approximately 74 months
Time to prostate specific antigen (PSA) progression (TTPSAP)
Time to prostate specific antigen (PSA) progression (TTPSAP) is defined as time from randomization to first PSA progression 1. First PSA progression 1 is defined as a rising PSA confirmed on repeated measurement at least 3 weeks later, and at least greater than 25% and \>= 2 ng/mL above nadir or baseline, whichever is lower. In the absence of PSA progression, TTPSAP will be censored at the last PSA measurement.
Time frame: From date of randomization until date of first PSA progression, assessed up to approximately 74 months
Radiographic Progression Free Survival (rPFS)
Radiographic progression free survival (rPFS) is defined as the time from randomization to first documentation of confirmed radiographic progressive disease or death due to any cause (whichever occurs first) by conventional imaging (i.e., CT/MRI and bone scans) using RECIST 1.1. The rPFS will be analyzed based on BIRC and Investigator assessments respectively.
Time frame: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 74 months
Time to next therapy (local or systemic)
Time to next therapy (local or systemic) is defined as the time from randomization to initiation of the next line of therapy (local or systemic). Next-line therapy is defined as the first new (local or systemic) anti-neoplastic therapy initiated after discontinuation of study treatment regardless of end of treatment (EOT) reason.
Time frame: From date of randomization until initiation of the next line of therapy (local or systemic), assessed up to approximately 74 months
24-month prostate-specific antigen (PSA) progression free survival (PFS)
24-month PSA PFS is defined as PSA PFS at 24 months. PSA PFS is defined as the time from date of randomization to the date of first documented PSA progression 2 or death from any cause, whichever occurs first. PSA progression 2 is defined as a PSA concentration above the nadir (or baseline if lower) of \>= 0.5 ng/mL, confirmed by repeated measurement at least 3 weeks later. PSA PFS will be censored if no PSA PFS event is observed before the first to occur analysis cut-off date. The censoring date will be the date of the last adequate tumor assessment prior to cut-off.
Time frame: From date of randomization until date of first documented PSA progression 2 or death from any cause, whichever occurs first, assessed up to approximately 74 months
Time to symptomatic progression
Time to symptomatic progression is defined as time from randomization to the date of first documented event for any of the following, whichever occurs first: development of symptomatic skeletal event, escalation in cancer-related pain or worsening of disease-related symptoms leading to the initiation of a new systemic anticancer therapy, development of clinically significant symptoms due to local or regional tumor progression leading to surgery or radiation therapy.
Time frame: From date of randomization until date of first documented symptomatic progression, assessed up to approximately 74 months
Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire
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.
Time frame: From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT) Questionnaire
The FACT-RNT (Functional Assessment of Cancer Therapy - Radionuclide Therapy) is a Patient Reported Outcomes (PRO) new measure developed using FACIT specific questions (items), selected from FACIT item bank, to assess treatment-related symptoms of special interest associated with radioligand therapies. The FACT-RNT contains items assessing dry mouth, dry eyes, vomiting, diarrhea, constipation, loss of appetite, fatigue, impact of fatigue, bone pain, and isolation due to illness or treatment. FACT-RNT score range 0 to 60, with higher score indicating better quality of life.
Time frame: From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
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.
Time frame: From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
European Quality of Life (EuroQol) - 5 Domain 5 Level scale (EQ-5D- 5L)
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.
Time frame: From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
Time to First Symptomatic Skeletal Event (TTSE)
Time to first symptomatic skeletal event (TTSSE) is defined as date of randomization to the date of first new SSE or death from any cause, whichever occurs first. Symptomatic skeletal events (SSE) will be defined by the occurrence of any of the following (whichever occurs earlier): symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain.
Time frame: From date of randomization till end of treatment (EOT) or death, whichever happens first, assessed up to approximately 74 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Time frame: From date of randomization up till 42 day safety Follow-up, assessed up to approximately 74 months
Dose modifications and intensity for AAA617
Dose modifications (dose interruptions and reductions) and dose intensity for AAA617 will be assessed and summarized using descriptive statistics.
Time frame: From date of randomization until end of treatment (EOT), assessed up to approximately 30 months
Overall survival (OS)
Overall Survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. OS time for participants who are alive at the end of the study or are lost to follow-up will be censored at the date of last contact.
Time frame: From date of randomization until date of death from any cause, assessed up to approximately 74 months
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 144 sites across 27 countries. Choose a country and city above to see the rest.
Plan to share: 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
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Apr 2028, 49 months after the start.
Of 126 industry-sponsored phase 3 interventional studies under Prostatic Neoplasms, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 53. This study's planned 49 months is above that.
Counting every sponsor, half of 265 studies reached it within 57 months; a quarter within 31 and three quarters within 100.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Lutetium (¹⁷⁷Lu) vipivotide tetraxetan