Metastatic Castration-Resistant Prostate CancerPhase 1RADIODOSENCT06531499
A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study
A Phase 1 study testing AAA617, Gonadotropin-releasing hormone (GnRH) analogues and Gonadotropin-releasing hormone (GnRH) antagonists in people with Metastatic Castration-Resistant Prostate Cancer, run by Novartis Pharmaceuticals at 22 sites in 6 countries.
Trial summary
The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Metastatic Castration-Resistant Prostate Cancer
- What is being tested?
- AAA617, Gonadotropin-releasing hormone (GnRH) analogues and Gonadotropin-releasing hormone (GnRH) antagonists
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 22 sitesin 6 countries
- Study dates
- 11 Nov 2024to 24 Apr 2029
- Phase
- Phase 1
- 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
- Signed informed consent must be obtained prior to participation in the study.
- Participants must be adults ≥ 18 years of age.
- Participants must have an ECOG performance status ≤ 1.
- Participants must have histological confirmation of adenocarcinoma of the prostate.
- Participants must be PSMA-positive per 68Ga-PSMA PET/CT scans at baseline
- Participants must have a castrate level of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L) either by pharmaceutical or surgical methods.
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- Participants must have progressed only once on prior second generation ARPIs
- Documented progressive mCRPC
- Participants must have ≥ 1 metastatic lesion by conventional imaging that is present on screening/baseline CT, MRI, or bone scan
- Renal: eGFR ≥ 60 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies except alopecia.
Who cannot join
- Previous treatment with any of the following within 6 months of study enrollment: Strontium 89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation
- Any previous radioligand therapy.
- Prior treatment with cytotoxic chemotherapy for metastatic castration-resistant or metastatic hormone-sensitive prostate cancer (mHSPC) (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy [including monoclonal antibodies]. [Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed].
- Concurrent therapies: cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological, or investigational therapy
- History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
- Concurrent serious acute or chronic nephropathy and/or moderate to severe renal impairment as determined by the principal investigator.
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- Diagnosed with other active malignancies that are expected to alter life expectancy or may interfere with disease assessment
- Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment.
- Concurrent urinary outflow obstruction or unmanageable urinary incontinence
- History of somatic or psychiatric disease/condition that may interfere with the aims and assessments of the study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
22 sites in 6 countries.
22 sites in 6 countries
Germany7 sites
Novartis Investigative Site
Aachen, 52074
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
München, 80377
Novartis Investigative Site
Rostock, 18057
Novartis Investigative Site
Wuppertal, North Rhine-Westphalia, 42283
United States5 sites
University of California LA
Los Angeles, California, 90095
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Stanford University
Palo Alto, California, 94304
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Wash U School of Medicine
St Louis, Missouri, 63110
Spain4 sites
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Madrid, 28222
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
United Kingdom3 sites
Novartis Investigative Site
Birmingham, West Midlands, B15 2TH
Novartis Investigative Site
Glasgow, G12 0YN
Novartis Investigative Site
Sutton, Surrey, SM2 5PT
Switzerland2 sites
Novartis Investigative Site
Bellinzona, 6500
Novartis Investigative Site
Bern, 3010
About this study
Official title: A Phase I, Open-label, Multi-center Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer
The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).
Read the detailed description
The study includes screening period, treatment period, and a post-treatment follow-up period.
Screening Period: Approximately 106 participants will be enrolled to receive up to12 consecutive cycles of AAA617. Potential participants will be assessed for eligibility by verifying their baseline PSMA PET scan for mandatory confirmation of PSMA positivity prior to first cycle by local review.
Treatment Period: Eligible participants will be treated with up to 12 cycles of 7.4 GBq AAA617 intravenously every 6 weeks, until radiographic progression, toxicity leading to treatment discontinuation, death, loss to follow-up, or withdrawal of consent, whichever occurs first. During treatment period, all participants who complete the initial 6 cycles of AAA617 treatment will undergo an additional PSMA-PET scan after Cycle 6 to re-assess PSMA expression level and to reassess eligibility of participants to receive additional AAA617 treatment cycles.
Post-Treatment Follow-Up: All participants will undergo a PSMA-PET scan at end of treatment (EOT). The post-treatment follow-up period will consist of EOT; 42-days safety; EOT RLI; safety, survival and rPFS follow-up visits.
The planned duration of treatment period is up to 74 weeks with treatment given every 6 weeks. Participants may be discontinued from treatment earlier due to unacceptable toxicity or disease progression, and/or at the discretion of the Investigator or the participant.
- Being tested
- AAA617, Gonadotropin-releasing hormone (GnRH) analogues, Gonadotropin-releasing hormone (GnRH) antagonists
- Keywords
- Phase 1, RADIODOSE, AAA617, metastatic castration-resistant prostate cancer, radiation dosimetry, mCRPC, Prostate-specific membrane antigen (PSMA), Dosimetry, [68Ga]Ga-PSMA-11, gallium (68Ga) gozetotide, [177Lu]Lu-PSMA-617, lutetium (177Lu) vipivotide tetraxetan, Radioligand Imaging (RLI), Radioligand Therapy (RLT)
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]Lu-PSMA-617
[177Lu]Lu-PSMA-617 will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%), every 6 weeks for up to 12 cycles.
Gonadotropin-releasing hormone (GnRH) analoguesDrug
Anatomical Therapeutic Chemical [ATC] code L02AE
Gonadotropin-releasing hormone (GnRH) antagonistsDrug
Degarelix, Relugolix
| Study group | Role | What they receive |
|---|---|---|
| AAA617 | Experimental | All participants will receive the investigational product AAA617 (7.4 GBq ±10%). Receives: Drug: AAA617; Drug: Gonadotropin-releasing hormone (GnRH) analogues; Drug: Gonadotropin-releasing hormone (GnRH) antagonists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time activity curves (TACs) and absorbed radiation dose of AAA617 in organs
Time activity curve (TAC) will be generated from the amount radioactivity in one given tissue. Time integrated activity coefficient and absorbed dose will be calculated
Measured: From Cycle 1 to Cycle 12; cycle = 42 days
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The distribution of adverse events for Radioligand Therapy (RLT) will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters.
Adverse event monitoring should be continued for at least 42 days following the end of treatment (EOT) visit.
Participants receiving the study treatment will continue to be followed for safety every 12 weeks during the long-term follow-up for selected adverse events
Measured: For up to 12 cycles in taxane-naive participants with progressive PSMA-positive mCRPC with nrmal kidney function or mild renal impairment; cycle = 42 days
Percentage of participants with AAA617 dose reductions, interruptions and discontinuations
The assessment of tolerability will be based on the frequency of participants with dose interruptions, reductions, and study treatment discontinuations. Dose reduction will be based on the worst toxicity demonstrated at the last dose.
Measured: Up to 42 (+7) days after last AAA617 dose administration (Safety Follow-up)
Secondary outcomes (15)
Time activity curves (TACs) and absorbed radiation dose AAA617 in tumors
Time activity curves (TACs) will be generated from the amount of radioactivity in one given tissue at a given moment. TACs will be fitted to mono- and bi-exponential curves. Time integrated activity coefficient and absorbed dose will be calculated.
Measured: For up to 12 cycles; cycle = 42 days
Pharmacokinetic ( PK) concentration of AAA617 in blood over time
PK concentrations will be listed by patient and visit/sampling time point. The descriptive summary statistics will be provided by visit/sampling time point.
Measured: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12, cycle = 42 days
Pharmacokinetic (PK) parameter Cmax of AAA617 from blood radioactivity data
Derived PK parameter, Cmax will be listed by patient and visit. The descriptive summary statistics will be provided by visit.
Cmax is the maximum drug concentration after dosing.
Measured: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days
PK parameter Tmax of AAA617 from blood radioactivity data
Derived PK parameter Tmax, will be listed by patient and visit. The descriptive summary statistics will be provided by visit.
Tmax is the time to reach the maximum concentration.
Measured: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days
PK parameter AUC of AAA617 from blood radioactivity data
Derived PK parameter AUC will be listed by patient and visit. The descriptive summary statistics will be provided by visit.
AUC: Area under the concentration-time curve.
Measured: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days
PK parameter CL of AAA617 from blood radioactivity data
Derived PK parameter CL will be listed by patient and visit. The descriptive summary statistics will be provided by visit.
Clearance (CL): Rate at which the body eliminates the drug.
Measured: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days
PK parameter VZ of AAA617 from blood radioactivity data
Derived PK parameter Vz will be listed by patient and visit. The descriptive summary statistics will be provided by visit.
Vz: volume of distribution during the terminal phase (Vz).
Measured: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days
PK parameter terminal T1/2 of AAA617 from blood radioactivity data
Derived PK parameter terminal T1/2 will be listed by patient and visit. The descriptive summary statistics will be provided by visit.
T1/2: Terminal half life.
Measured: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11, and Cycle 12; cycle = 42 days
Overall response rate (ORR)
ORR is defined as the proportion of participants with BOR of confirmed CR or PR per investigator assessment and according to Prostate Cancer Working Group 3 (PCWG3) modified-RECIST v1.1.
Measured: From first patient first visit (FPFV) to end of study, until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 58 months
Disease Control rate (DCR)
DCR is defined as the percentage of CR, PR, stable disease or non-CR/non-progressive disease (PD) per investigator assessment and according to PCWG3 modified-RECIST v1.1 assessment in soft tissue, lymph node, and visceral lesions.
Measured: From first patient first visit (FPFV) to end of study, until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 58 months
Duration of response (DOR)
DOR is defined as the duration of time between the date of the first documented BOR (CR or PR) per investigator assessment according to PCWG3 modified-RECIST v1.1 and the date of first documented progression or death due to any cause.
Measured: From first patient first visit (FPFV) to end of study, until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 58 months
Radiographic Progressive free survival (rPFS)
rPFS defined as the time from the date of first dose of study treatment to the date of the first documented radiographic disease progression as assessed by investigator and PCWG3 modified-RECIST v1.1 criteria or death due to any cause, whichever occurs first.
Measured: From first patient first visit (FPFV) to end of study, until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 58 months
Prostate specific antigen (PSA) response
PSA response is defined as percentage of participants who achieve any decrease from baseline that is confirmed by a second PSA measurement ≥4 weeks. Participants with any decrease in PSA will also be summarized by visit.
Measured: Baseline, (Cycle (C), Day (D)) C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, C6D42, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, End Of Treatment (EOT), 6 weeks after EOT, every 12 weeks after EOT up to 12 months; each cycle = 42 days
Overall survival (OS)
Overall survival is defined as the time from the first dose of study treatment to death due to any cause.
Measured: Cycle 1 to death event, approx. 5 years, (cycle = 42 days)
Duration of exposure to AAA617 and dose intensity
Duration of exposure:
Dose intensity is computed as the ratio of actual cumulative dose received and actual duration of exposure.
Measured: during treatment period (74 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start11 Nov 2024
- Primary completion24 Apr 2029 (estimated)
- Study completion24 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-Resistant Prostate CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be assigned to a treatment arm based on their PSMA expressed target per PET images (based on central read).
- Masking
- None (open label)
- Enrolment
- 110 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
- NCT06531499
- Sponsor's protocol ID
- CAAA617A12101
- Other IDs
- 2024-512338-13
- Acronym
- RADIODOSE
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multi-center Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT06531499
- Acronym / sponsor ID
- RADIODOSE / CAAA617A12101
- Keywords
- Phase 1, RADIODOSE, AAA617, metastatic castration-resistant prostate cancer, radiation dosimetry, mCRPC, Prostate-specific membrane antigen (PSMA), Dosimetry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 24 Apr 2029 (estimated)
- Study completion
- 24 Apr 2029 (estimated)
- First posted
- 1 Aug 2024 (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 the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).
Detailed description
The study includes screening period, treatment period, and a post-treatment follow-up period.
Screening Period: Approximately 106 participants will be enrolled to receive up to12 consecutive cycles of AAA617. Potential participants will be assessed for eligibility by verifying their baseline PSMA PET scan for mandatory confirmation of PSMA positivity prior to first cycle by local review.
Treatment Period: Eligible participants will be treated with up to 12 cycles of 7.4 GBq AAA617 intravenously every 6 weeks, until radiographic progression, toxicity leading to treatment discontinuation, death, loss to follow-up, or withdrawal of consent, whichever occurs first. During treatment period, all participants who complete the initial 6 cycles of AAA617 treatment will undergo an additional PSMA-PET scan after Cycle 6 to re-assess PSMA expression level and to reassess eligibility of participants to receive additional AAA617 treatment cycles.
Post-Treatment Follow-Up: All participants will undergo a PSMA-PET scan at end of treatment (EOT). The post-treatment follow-up period will consist of EOT; 42-days safety; EOT RLI; safety, survival and rPFS follow-up visits.
The planned duration of treatment period is up to 74 weeks with treatment given every 6 weeks. Participants may be discontinued from treatment earlier due to unacceptable toxicity or disease progression, and/or at the discretion of the Investigator or the participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be assigned to a treatment arm based on their PSMA expressed target per PET images (based on central read).
| Arm | Type | Receives |
|---|---|---|
| AAA617 | Experimental | Drug: AAA617, Drug: Gonadotropin-releasing hormone (GnRH) analogues, Drug: Gonadotropin-releasing hormone (GnRH) antagonistsAll participants will receive the investigational product AAA617 (7.4 GBq ±10%). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent must be obtained prior to participation in the study.
- Participants must be adults ≥ 18 years of age.
- Participants must have an ECOG performance status ≤ 1.
- Participants must have histological confirmation of adenocarcinoma of the prostate.
- Participants must be PSMA-positive per 68Ga-PSMA PET/CT scans at baseline
Key exclusion criteria (11 listed)
- Previous treatment with any of the following within 6 months of study enrollment: Strontium 89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation
- Any previous radioligand therapy.
- Prior treatment with cytotoxic chemotherapy for metastatic castration-resistant or metastatic hormone-sensitive prostate cancer (mHSPC) (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy [including monoclonal antibodies]. [Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed].
- Concurrent therapies: cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological, or investigational therapy
- History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
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]Lu-PSMA-617[177Lu]Lu-PSMA-617 will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%), every 6 weeks for up to 12 cycles. | Drug | AAA617 |
| Gonadotropin-releasing hormone (GnRH) analoguesAnatomical Therapeutic Chemical [ATC] code L02AE | Drug | AAA617 |
| Gonadotropin-releasing hormone (GnRH) antagonistsDegarelix, Relugolix | Drug | AAA617 |
Primary outcome
Time activity curves (TACs) and absorbed radiation dose of AAA617 in organs
Time frame: From Cycle 1 to Cycle 12; cycle = 42 days
Time activity curve (TAC) will be generated from the amount radioactivity in one given tissue. Time integrated activity coefficient and absorbed dose will be calculated
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: For up to 12 cycles in taxane-naive participants with progressive PSMA-positive mCRPC with nrmal kidney function or mild renal impairment; cycle = 42 days
The distribution of adverse events for Radioligand Therapy (RLT) will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters. Adverse event monitoring should be continued for at least 42 days following the end of treatment (EOT) visit. Participants receiving the study treatment will continue to be followed for safety every 12 weeks during the long-term follow-up for selected adverse events
Percentage of participants with AAA617 dose reductions, interruptions and discontinuations
Time frame: Up to 42 (+7) days after last AAA617 dose administration (Safety Follow-up)
The assessment of tolerability will be based on the frequency of participants with dose interruptions, reductions, and study treatment discontinuations. Dose reduction will be based on the worst toxicity demonstrated at the last dose.
15 secondary outcomes
Time activity curves (TACs) and absorbed radiation dose AAA617 in tumors
Time frame: For up to 12 cycles; cycle = 42 days
Pharmacokinetic ( PK) concentration of AAA617 in blood over time
Time frame: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12, cycle = 42 days
Pharmacokinetic (PK) parameter Cmax of AAA617 from blood radioactivity data
Time frame: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days
PK parameter Tmax of AAA617 from blood radioactivity data
Time frame: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days
PK parameter AUC of AAA617 from blood radioactivity data
Time frame: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days
PK parameter CL of AAA617 from blood radioactivity data
Time frame: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days
PK parameter VZ of AAA617 from blood radioactivity data
Time frame: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days
PK parameter terminal T1/2 of AAA617 from blood radioactivity data
Time frame: Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11, and Cycle 12; cycle = 42 days
Overall response rate (ORR)
Time frame: From first patient first visit (FPFV) to end of study, until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 58 months
Disease Control rate (DCR)
Time frame: From first patient first visit (FPFV) to end of study, until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 58 months
Duration of response (DOR)
Time frame: From first patient first visit (FPFV) to end of study, until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 58 months
Radiographic Progressive free survival (rPFS)
Time frame: From first patient first visit (FPFV) to end of study, until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 58 months
Prostate specific antigen (PSA) response
Time frame: Baseline, (Cycle (C), Day (D)) C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, C6D42, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, End Of Treatment (EOT), 6 weeks after EOT, every 12 weeks after EOT up to 12 months; each cycle = 42 days
Overall survival (OS)
Time frame: Cycle 1 to death event, approx. 5 years, (cycle = 42 days)
Duration of exposure to AAA617 and dose intensity
Time frame: during treatment period (74 weeks)
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 20 Oct 2026.
- Individual participant dataSharing planned: No. 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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.
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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
22 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AAA617, Gonadotropin-releasing hormone (GnRH) analogues and Gonadotropin-releasing hormone (GnRH) antagonists in people with Metastatic Castration-Resistant Prostate Cancer, run by Novartis Pharmaceuticals at 22 sites in 6 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 11 inclusion and 11 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 20 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 22 sites in Germany, United States, Spain, United Kingdom, Switzerland and 1 more country. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Time activity curves (TACs) and absorbed radiation dose of AAA617 in organs (time frame: From Cycle 1 to Cycle 12; cycle = 42 days). The study lists 3 primary outcomes in all. 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 20 Oct 2026.