Phase II Study on Monitoring Prostate Cancer with PSMA-PET and Radiotherapy

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT07210086

Provider View

This study is exploring how PSMA-PET scans and blood tests can help track prostate cancer progression and response to radiotherapy. It aims to detect early cancer changes before PSA levels rise and understand how cancer responds to treatment over time.

Patient Parameters

Program Overview

The study is investigating the use of PSMA-PET scans and circulating tumor DNA (ctDNA) tests to monitor prostate cancer progression and response to radiotherapy. It aims to find out how often early cancer progression is detected on PSMA-PET before PSA levels increase, examine how cancer lesions respond to radiotherapy at 6 and 12 months, and explore the relationship between PSMA-PET scan results and ctDNA changes.

Description

The main goal of this study is to see how often early cancer progression is detected on PSMA-PET scans before PSA levels rise.

Secondary goals include:

  • Observing how cancer lesions respond to radiotherapy at 6 and 12 months and how this relates to PSA changes and later cancer progression.
  • Monitoring changes in ctDNA levels after radiotherapy aimed at metastatic cancer sites.
  • Understanding the relationship between PSMA-PET scan results and ctDNA changes.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent.
  • Age 18 or older.
  • Good overall health with a performance status score of 70 or higher.
  • Diagnosed with castration-sensitive prostate adenocarcinoma, with rising PSA levels.
  • Have newly diagnosed prostate cancer with up to five metastatic sites outside the pelvis, or have previously treated prostate cancer with up to five progressing metastatic sites outside the pelvis.
  • Cancer must be measurable by standard criteria.
  • Eligible for radiation therapy aimed at all metastatic sites.
  • Primary prostate cancer site is controlled or will be treated as part of the study.
  • Baseline PSMA-PET imaging is acceptable if done before starting radiation therapy.
  • Agree to use effective birth control or abstain from heterosexual activity during the study and for 30 days after the last treatment.

Exclusion Criteria

  • Planning to receive lifelong or intermittent hormone therapy (ADT).
  • Have received more than 3 months of hormone therapy before joining the study.
  • Cannot receive flotufolastat F 18.
  • Have more than five metastatic sites outside the pelvis or metastases in the brain or liver.
  • Have more than five progressing metastatic sites outside the pelvis or metastases in the brain or liver.
  • Have HIV, hepatitis B, or hepatitis C unless under control with treatment.
  • Have allergies to similar compounds as the study agent.
  • Cannot undergo PSMA-PET scans.
  • Have uncontrolled illness or another active cancer that could interfere with the study.
  • Any condition that the investigator believes would make participation unsafe.
  • May not be able to comply with study procedures.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

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