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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

NCT07698535 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-07-17

No results posted yet for this study

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 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.

Conditions

  • Metastatic Castration-Resistant Prostate Adenocarcinoma
  • Stage IVB Prostate Cancer AJCC v8

Interventions

DRUG

Lutetium Lu 177 Vipivotide Tetraxetan

Given IV

PROCEDURE

Cell-free Circulating Tumor DNA Assay

Undergo ctDNA TF testing

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Docetaxel

Given IV

PROCEDURE

PSMA PET Scan

Undergo PSMA PET

PROCEDURE

Single Photon Tomography and Computed Tomography Scan

Undergo SPECT/CT

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Sponsors & Collaborators

Principal Investigators

  • Michael Schweizer, MD · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2029-07-05
Completion
2029-07-05
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07698535 on ClinicalTrials.gov