The LUNAR Study: 177-Lutetium-PSMA Before Targeted Radiation for Treating Recurrent Prostate Cancer

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT05496959

Provider View

This study is exploring whether using a radioactive drug, 177-Lutetium-PSMA, before targeted radiation therapy can improve treatment outcomes for patients with prostate cancer that has returned after previous treatment.

Patient Parameters

Program Overview

This phase II clinical trial is testing if giving a radioactive drug called 177-Lutetium-PSMA before a precise form of radiation therapy, known as stereotactic body radiotherapy (SBRT), can better control prostate cancer that has come back in 1-5 spots after earlier treatment. The radioactive drug aims to deliver radiation directly to cancer cells, sparing healthy cells, while SBRT targets tumors with high precision, potentially reducing side effects and treatment time. The study hopes that using 177-Lutetium-PSMA before SBRT will make the radiation therapy more effective.

Description

The main goal of this study is to see how long patients with recurrent prostate cancer can live without the cancer getting worse after receiving either just SBRT or SBRT combined with the radioactive drug 177-Lutetium-PSMA. The study will use special scans and blood tests to monitor cancer progression and treatment effects.

Secondary goals include evaluating:

  • How well the cancer is controlled at the site of radiation and elsewhere in the body.
  • The side effects experienced by patients.
  • The quality of life reported by patients.
  • How long patients can go without needing hormone therapy.
  • The control of cancer at the radiation site after 12 months.
  • The time it takes for cancer to progress locally or spread to new areas.

The study will also look at cancer cells in the blood and immune system responses over time.

Participants will be randomly assigned to one of two groups:

  • Group 1: Receives SBRT alone over 10-20 days.
  • Group 2: Receives 177-Lutetium-PSMA through an IV on two occasions before starting SBRT over 10-20 days.

After treatment, patients will have follow-up visits at regular intervals for up to five years to monitor their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Have prostate cancer that has returned in 1-5 spots outside the prostate, confirmed by a specific scan.
  • Be 18 years or older.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2.
  • Not require urgent radiation treatment.
  • Have a confirmed diagnosis of prostate adenocarcinoma.
  • Meet specific blood count and organ function criteria.
  • Agree to use effective birth control during the study and for three months after the last treatment.
  • Be able to understand and sign a consent form.

Exclusion Criteria

  • Have a type of prostate cancer called neuroendocrine or small cell carcinoma.
  • Have prostate cancer that is resistant to hormone therapy.
  • Have received hormone therapy within six months before joining the study.
  • Be receiving other cancer treatments.
  • Have spinal cord compression or cannot lie flat.
  • Have allergies to the study drug components.
  • Have certain levels of kidney or liver function outside the study's limits.
  • Have newly diagnosed metastatic disease.

Locations

FACILITYZIPCITYSTATE
UCLA / Jonsson Comprehensive Cancer Center90095Los AngelesCalifornia

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