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Metastatic Castration-Resistant Prostate AdenocarcinomaPhase 2NCT07698535

Measuring Circulating Tumor Deoxyribonucleic Acid Tumor Fraction to Guide Early 177Lu-PSMA-617 Treatment Discontinuation in Patients With Metastatic Castration-Resistant Prostate Cancer, DYNAMO Trial

A Phase 2 study testing Lutetium Lu 177 Vipivotide Tetraxetan, Cell-free Circulating Tumor DNA Assay and Computed Tomography in people with Metastatic Castration-Resistant Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, run by University of Washington at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This clinical trial studies whether measuring circulating tumor deoxyribonucleic acid (ctDNA) tumor fraction (TF) can be used to help guide the early stopping (discontinuation) of lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) in patients with castration-resistant prostate cancer that has spread from where it… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Lutetium Lu 177 Vipivotide Tetraxetan, Cell-free Circulating Tumor DNA Assay and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
15 Nov 2026to 5 Jul 2029
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide informed consent
  • Adult males ≥ 18 years age
  • History of histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine or small cell differentiation. If histology is not available, patients must have metastatic disease typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes)
  • Evidence of metastatic disease on bone scan or CT scan
  • Patient must have evidence of castration- resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 [PCWG3] criteria) and a castrate serum testosterone level (i.e., ≤ 50 mg/dL)
  • Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL
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  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Prior treatment and progression on at least one androgen receptor pathway inhibitor (ARPI), in either castration-sensitive or castration-resistant setting
  • Eligible for treatment with either 177Lu-PSMA-617 or docetaxel as per their respective Food and Drug Administration (FDA) labels
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Hemoglobin ≥ 9 g/dL
  • Creatinine clearance ≥ 50 ml/min (calculated by Cockcroft-Gault formula)
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome (direct bilirubin ≤ 1.5 x ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN. For patients with known Gilbert's Syndrome they must be ≤ 3 x ULN
  • Able to comply with study requirements including provision of peripheral blood samples at specified time points for correlative studies

Who cannot join

  • Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition that could interfere with patient safety or provision of informed consent to participate in this study
  • Evidence of metastatic neuroendocrine/small cell prostate cancer (NEPC). Note: baseline biopsy is not required
  • Patients receiving any systemic therapy (aside from a luteinizing hormone-releasing hormone [LHRH] analogue) or radiotherapy within 2 weeks prior to study treatment
  • Persistent toxicities (CTCAE grade > 2) from prior cancer therapy, excluding alopecia and stable neuropathy
  • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder or active, uncontrolled infection. Examples include, but are not limited to uncontrolled seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
  • Patients who are known to be serologically positive for human immunodeficiency virus (HIV) and a CD4 count < 200
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  • Patients with known active hepatitis (i.e. hepatitis B or C). Prior hepatitis C infection is allowed as long as polymerase chain reaction (PCR) is negative
  • Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery
  • Serious cardiac disorder, including but not limited to uncontrolled ventricular arrhythmia, recent (within 12 months) myocardial infarction, resting electrocardiogram (ECG) indicating Fridericia's corrected QT interval prolongation > 500ms, or congenital long QT syndrome
  • Prior systemic chemotherapy with taxane chemotherapy, including in hormone sensitive setting (e.g. docetaxel or cabazitaxel)
  • Brain metastases or active epidural disease (treated epidural disease is permitted)
  • Note: baseline brain imaging is not required
  • Contraindication to prednisone therapy including poorly controlled diabetes mellitus

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michael Schweizer, MD contact

206-606-6252

schweize@uw.edu

United States1 site, 1 recruiting

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Michael Schweizer, MD, 206-606-6252, schweize@uw.edu

    Michael Schweizer, MD

    Recruiting

Other trials in United States

About this study

Official title: Dynamic Assessments of Molecular Response to Guide Early 177Lu-PSMA-617 Treatment Discontinuation: The DYNAMO Study

This clinical trial studies whether measuring circulating tumor deoxyribonucleic acid (ctDNA) tumor fraction (TF) can be used to help guide the early stopping (discontinuation) of lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) in patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Many types of tumors tend to lose cells or release different types of cellular products including their deoxyribonucleic acid, which is referred to as ctDNA, into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for the disease to grow, spread, or get worse or come back after a period of improvement. ctDNA TF is a type of ctDNA measurement. Research has shown ctDNA TF may be a promising way to predict which patients will respond to 177Lu-PSMA-617 treatment. Measuring ctDNA TF may help doctors identify which patients may benefit from changing treatments sooner, which may be an effective way to guide early 177Lu-PSMA-617 treatment discontinuation in patients with metastatic castration-resistant prostate cancer.

Read the detailed description

OUTLINE:

CYCLES 1 AND 2: Patients receive 177Lu-PSMA-617 intravenously (IV) over 20-30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection with ctDNA TF testing at baseline and C2D1. Patients with undetectable ctDNA TF (< 3%) on C2D1 continue to receive 177Lu-PSMA-617 as above in the absence of disease progression or unacceptable toxicity. Patients with detectable ctDNA TF (≥ 3%) on C2D1 are randomized to 1 of 2 arms.

CYCLE 3+ ARM I: Starting with cycle 3, patients receive 177Lu-PSMA-617 IV over 20-30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

CYCLE 3+ ARM II: Starting with cycle 3, patients receive docetaxel IV on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Additionally, all patients undergo PSMA positron emission tomography (PET) during screening, single photon emission computed tomography (SPECT)/computed tomography (CT) on study, and additional blood sample collection as well as CT throughout the study.

After completion of study treatment, patients are followed up every 12 weeks for up to 1 year.

Being tested
Lutetium Lu 177 Vipivotide Tetraxetan, Cell-free Circulating Tumor DNA Assay, Computed Tomography, Docetaxel, PSMA PET Scan
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lutetium Lu 177 Vipivotide TetraxetanDrug

    Also called 177Lu-labeled PSMA-617, 177Lu-PSMA-617, Pluvicto, AAA 617

    Given IV

  • Cell-free Circulating Tumor DNA AssayProcedure or surgery

    Also called ctDNA Assay, Signatera

    Undergo ctDNA TF testing

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • DocetaxelDrug

    Also called Docecad, RP 56976, RP-56976, RP56976

    Given IV

  • PSMA PET ScanProcedure or surgery

    Also called Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

    Undergo PSMA PET

  • Single Photon Tomography and Computed Tomography ScanProcedure or surgery

    Also called SPECT/CT, SPECT/CT SCAN

    Undergo SPECT/CT

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

Study groups in NCT07698535
Study groupRoleWhat they receive
Cycles 1 and 2 (177Lu-PSMA-617, ctDNA testing)OtherPatients receive 177Lu-PSMA-617 IV over 20-30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection with ctDNA TF testing at baseline and C2D1. Patients with undetectable ctDNA TF (< 3%) on C2D1 continue to receive 177Lu-PSMA-617 as above in the absence of disease progression or unacceptable toxicity. Patients with detectable ctDNA TF (≥ 3%) on C2D1 are randomized to 1 of 2 arms. Additionally, patients undergo PSMA PET during screening, SPECT/CT on study, and additional blood sample collection as well as CT throughout the study.
Receives: Drug: Lutetium Lu 177 Vipivotide Tetraxetan; Procedure: Cell-free Circulating Tumor DNA Assay; Procedure: Computed Tomography; Procedure: PSMA PET Scan; Procedure: Single Photon Tomography and Computed Tomography Scan; Procedure: Biospecimen Collection
Cycle 3+ Arm I (177Lu-PSMA-617)Active comparatorStarting with cycle 3, patients receive 177Lu-PSMA-617 IV over 20-30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo PSMA PET during screening, SPECT/CT on study, and additional blood sample collection as well as CT throughout the study.
Receives: Drug: Lutetium Lu 177 Vipivotide Tetraxetan; Procedure: Computed Tomography; Procedure: PSMA PET Scan; Procedure: Single Photon Tomography and Computed Tomography Scan; Procedure: Biospecimen Collection
Cycle 3+ Arm II (docetaxel)Active comparatorStarting with cycle 3, patients receive docetaxel IV on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo PSMA PET during screening, SPECT/CT on study, and additional blood sample collection as well as CT throughout the study.
Receives: Procedure: Computed Tomography; Drug: Docetaxel; Procedure: PSMA PET Scan; Procedure: Single Photon Tomography and Computed Tomography Scan; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and proportion among those recruited with detectable circulating tumor deoxyribonucleic acid (ctDNA) tumor fraction who undergo randomization

    Will be analyzed descriptively. Among patients who initiate lutetium Lu 177 vipivotide tetraxetan and undergo cycle (C) 2 day (D) 1 ctDNA tumor fraction assessment, the number (and proportion among those recruited) with detectable ctDNA tumor fraction who undergo randomization will be reported with a two-sided 95% Wilson confidence interval.

    Measured: Up to 2 cycles (Cycle length = 6 weeks)

  2. Number of patients screened, enrolled, evaluable for C2D1 ctDNA tumor fraction and for who cycle 3 is administered

    Will report the number of patients screened, enrolled, evaluable for C2D1 (week 13) ctDNA tumor fraction, classified as having detectable versus undetectable ctDNA tumor fraction, and for who cycle 3 is administered. Reasons for failure to undergo C1D28 ctDNA assessment or randomization will be tabulated.

    Measured: Up to cycle 3 administration (Cycle length = 6 weeks)

Secondary outcomes (5)

  1. Radiographic progression free survival (PFS)

    Will be estimated in the subset of patients who undergo randomization. Disease progression assessed per modified Response Evaluation Criteria in Solid Tumors criteria or the Prostate Cancer Working Group 3 criteria for bone lesions. Clinical progression as determined by the treating physician. Will be estimated using the Kaplan-Meier method. Differences between groups will be evaluated using the log-rank test and the hazard ratio from a Cox regression model with treatment group as the predictor variable following assessment of proportional hazards. Will also visualize PFS point estimates and 95% confidence interval (CI) bands over time and report median and 95% CIs of PFS for each group.

    Measured: From randomization to disease progression, clinical progression, or death, whichever occurs first, assessed up to 1 year

  2. Overall survival

    Will be estimated in the subset of patients who undergo randomization. Will be estimated using the Kaplan-Meier method. Differences between groups will be evaluated using the log-rank test and the hazard ratio from a Cox regression model with treatment group as the predictor variable following assessment of proportional hazards.

    Measured: From the start of treatment until death from any cause, assessed up to 1 year

  3. Prostate-specific antigen (PSA) PFS

    Will be estimated in the subset of patients who undergo randomization. Will be estimated using the Kaplan-Meier method. Differences between groups will be evaluated using the log-rank test and the hazard ratio from a Cox regression model with treatment group as the predictor variable following assessment of proportional hazards.

    Measured: From the start of treatment until PSA progression, assessed up to 1 year

  4. Proportion of patients with a ≥ 50% decline in PSA from baseline (PSA50) response rate

    Will be estimated in the subset of patients who undergo randomization. Will be reported as a percentage with 95% CI calculated using Wilson's method. Changes in PSA from baseline, with patients achieving PSA50, may be visualized using waterfall plots.

    Measured: Up to 1 year

  5. Duration of response

    Will be estimated in the subset of patients who undergo randomization.

    Measured: From the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completion5 Jul 2029 (estimated)
  4. Study completion5 Jul 2029 (estimated)

Resources

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
Sequential
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07698535
Sponsor's protocol ID
RG1126448
Other IDs
NCI-2026-03971, FHIRB0021269
Status last verified
Jul 2026
First submitted
25 Jun 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lutetium Lu 177 Vipivotide Tetraxetan, Cell-free Circulating Tumor DNA Assay and Computed Tomography in people with Metastatic Castration-Resistant Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, run by University of Washington at 1 site in United States.

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 16 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 19 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 1 site in United States. 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?

Contact Michael Schweizer, MD (206-606-6252, schweize@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and proportion among those recruited with detectable circulating tumor deoxyribonucleic acid (ctDNA) tumor fraction who undergo randomization (time frame: Up to 2 cycles (Cycle length = 6 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07698535.

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 19 Oct 2026.

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