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Not yet recruitingPhase 1

Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer

A Phase 1 Study to Investigate Safety of Escalating Cycle 1 Dose of Lu-177-PSMA-617 Radioligand Therapy (RLT) in Metastatic Castration Resistant Prostate Cancer (mCRPC): The ESCENDO Trial

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
All sexes
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

Not stated in the study description — ask the study team about visits and procedures.

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

This study tests the safety, side effects, and best first dose of Lu-177-PSMA-617, a radioactive drug that targets prostate cancer cells. It is for adults whose prostate cancer has spread and keeps growing despite very low testosterone levels. The study gives a larger first dose and fewer treatments, without increasing the total amount of radiation given.

This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to other places in the body (metastatic). Lu-177-PSMA-617 is a radioactive drug. It binds to a protein called prostate-specific membrane antigen (PSMA), which is found on prostate cancer tumor cells. Lu-177-PSMA-617 gives off radiation that may kill these tumor cells. It is a type of radioconjugate. Lu-177-PSMA-617 is currently used in a series of 6 intravenous infusions of the standard dosage, each separated by 6 weeks from the previous infusion. Investigators have observed that the first therapy administration (cycle 1) delivers better radiation treatment to the cancer than each of the following 5 infusions. Giving an increased dosage of Lu-177-PSMA-617 in treatment cycle 1 may have a better effect on metastatic castration-resistant prostate cancer than the standard dosage. The study does not change the total cumulative activity from what is used in the standard dosage treatment but gives an increased dosage in cycle 1 and reduces the total number of cycles.

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

Eligibility

Who can join

  • Be age 18 or older.
  • Qualify for standard Lu-177-PSMA-617 treatment. A PSMA PET/CT scan must show that cancer spots take up more of the scan tracer than the liver.
  • Be fully active or able to do light work, with limits only on hard physical activity.
  • Side effects from past cancer treatments must have improved to moderate or less severe.
  • Meet blood count limits: infection-fighting white blood cells at least 1,500/mm³, platelets at least 150,000/mm³, and hemoglobin at least 10 g/dL.
  • Meet kidney and liver blood test limits, including a kidney filtering rate of at least 60 mL/min and albumin, a blood protein, above 3 g/dL.
  • Use effective birth control during treatment and for 14 weeks after the last dose.
  • Be able to understand the study and willing to sign a consent form.

Who can't join

  • Do not qualify for standard Lu-177-PSMA-617 treatment.
  • Have widespread cancer in the bone marrow, where blood cells are made, as seen on a PSMA PET/CT scan.
  • Have had radioligand therapy before—a radioactive drug that targets cancer cells.
  • Have a blocked flow of urine or loss of bladder control that cannot be managed.
  • Have a serious health condition that could prevent safe participation, such as severe heart failure, an inherited heart rhythm problem, an uncontrolled infection, or active hepatitis B or C.
  • Plan to start another cancer treatment or an experimental drug during study treatment, including chemotherapy or hormone therapy.
  • Take part in another experimental trial during this radioactive drug treatment or in the 30 days before it starts.

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

Official eligibility criteria

Inclusion Criteria: * Patients must be eligible for standard Lu-177-PSMA617 RLT for mCRPC, including PSMA PET/CT scan positive (lesion uptake \> liver uptake by visual assessment) * Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., prior chemotherapy, external beam radiation, brachytherapy, immunotherapy, etc.) * Patients must be ≥18 years of age * Patients must have an ECOG performance status of 0 or 1 * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 * Platelet count ≥ 150,000/mm\^3 * Hemoglobin ≥ 10.0 g/dL * Estimated glomerular filtration rate (EGFR) ≥ 60ml/min * Bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases * Albumin \> 3.0 g/dL * Use effective birth control methods during the treatment and for 14 weeks after the last Lu-177-PSMA-617 dose * Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Does not meet criteria for standard Lu-177-PSMA-617 RLT * Diffuse marrow involvement evident on Ga-68-PSMA PET/CT as assessed by study treating clinician * Prior RLT * Unmanageable concurrent bladder outflow obstruction or urinary incontinence * Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation * Plan to start any additional anti-cancer therapy or investigational agents during study therapy. Anti-cancer therapies include chemotherapy and endocrine therapy * Exclusion criteria for participation in other investigational trials: should not participate during RLT or 30 days prior to start of RLT

Study sites (1)

MI