The University of Miami UAdapt Trial for Prostate Cancer Treatment

Sponsor: University of Miami

Sponsor score: 40

ClinicalTrials ID:NCT06111313

This study is testing a new approach to treat non-metastatic prostate cancer using a special type of radiation therapy, with or without hormone therapy, to see how well it works and how it affects the cancer.

Patient Parameters

Program Overview

The Miami UAdapt Trial is a research study for men with certain types of prostate cancer that have not spread to other parts of the body. The study is looking at how effective a new type of radiation therapy, called Lattice Extreme Ablative Dose (LEAD) RT, is when used alone or with hormone therapy. The goal is to see if this treatment can help control the cancer better.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of prostate cancer through a biopsy.
  • Cancer is in stages T1 to T3, meaning it is still within or just outside the prostate.
  • No signs of cancer spreading to other parts of the body.
  • Gleason score between 6 and 10, which indicates the aggressiveness of the cancer.
  • PSA level of 100 ng/mL or less within 3 months before joining the study.
  • No previous radiation therapy to the pelvic area.
  • No history of complete prostate removal surgery.
  • No other active cancers, except for non-metastatic skin cancer or early-stage chronic lymphocytic leukemia.
  • Able to understand and sign a consent form.
  • Age between 35 and 85 years.
  • Normal testosterone levels within 3 months before joining the study.
  • Willing to follow the treatment plan, which may include hormone therapy after radiation.
  • Patients who cannot receive certain contrast agents due to allergies or kidney issues can still participate.

Exclusion Criteria

  • Previous radiation therapy to the pelvic area.
  • Previous hormone therapy for prostate cancer.
  • Previous or planned complete prostate removal surgery.
  • Evidence of cancer spreading to lymph nodes or other parts of the body.
  • Other active cancers, except for non-metastatic skin cancer or early-stage chronic lymphocytic leukemia.
  • Poor overall health status.
  • PSA level over 100 ng/mL or Gleason score less than 6.
  • Certain thyroid conditions.
  • Inability to understand and sign a consent form.
  • Unable to undergo MRI scans, except for those who cannot tolerate contrast agents.

Locations

FACILITYZIPCITYSTATE
University of Miami33136MiamiFlorida

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