RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Blood draws, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients also undergo blood sample collection with ctDNA TF testing at baseline and C2D1."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The DYNAMO trial tests whether measuring tumor DNA in blood can help doctors decide when to stop 177Lu-PSMA-617 treatment early. It is for men with prostate cancer that has spread and keeps growing despite very low testosterone levels.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men age 18 or older who can agree to join and follow study rules, including blood tests.
  • Prostate cancer confirmed by a tissue test, or cancer spread in a pattern typical of prostate cancer if tissue results are not available.
  • Cancer spread shown on a bone scan or CT scan.
  • Very low testosterone and rising PSA, a blood marker for prostate cancer, that meet study rules.
  • Able to care for yourself and be out of bed or a chair for at least half the day.
  • Cancer got worse after at least one drug that blocks male hormone signals.
  • Eligible for 177Lu-PSMA-617 or docetaxel under FDA-approved treatment rules.
  • Blood cell counts and kidney and liver tests meet study limits.

Who can't join

  • Serious or unstable health or mental health problems that could make joining unsafe or prevent informed consent, or an uncontrolled infection.
  • Neuroendocrine or small cell prostate cancer, which are less common cancer types, or cancer in the brain or active cancer near the spinal cord. Treated cancer near the spinal cord is allowed.
  • Cancer drug treatment or radiation within 2 weeks before study treatment, except an LHRH drug that lowers testosterone; or any past taxane chemotherapy, such as docetaxel or cabazitaxel.
  • Ongoing side effects from earlier cancer treatment above grade 2, except hair loss or stable nerve damage.
  • Known HIV with a CD4 immune cell count below 200, or active hepatitis B or C, which are liver infections. Past hepatitis C is allowed if a PCR test is negative.
  • Major surgery within 2 weeks before treatment, or not yet recovered from major surgery.
  • Serious heart problems, such as an uncontrolled abnormal heartbeat, a heart attack within 12 months, or certain abnormal heart rhythm tests.
  • Unable to take prednisone safely, including because of poorly controlled diabetes.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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

Study sites (1)

WA