Using a new imaging technique to detect prostate cancer in high-risk patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial evaluates the effectiveness of a novel PET tracer, PyL, for detecting prostate cancer metastases in patients with high-risk prostate cancer or biochemically recurrent prostate cancer. Participants will undergo PyL PET/CT imaging to identify lesions that may not be visible on standard imaging methods. The study aims to improve the detection of clinically significant metastases and confirm malignancy through biopsy when feasible. The trial will involve two cohorts: one with high-risk patients planning surgery or radiation, and another with patients experiencing biochemical relapse without evidence of disease on standard imaging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male ≥ 18 years of age.
2. Histologically confirmed adenocarcinoma of the prostate
3. Patients meet one of the follow criteria:

Cohort 1: High risk prostate cancer (PSA \>10, Gleason 8-10, or clinical stage \>T2c) and planned prostatectomy or radiation therapy or Cohort 2: Biochemical prostate cancer relapse (Prostate Specific Antigen (PSA) \> 0.2 ng/ml in patients following prostatectomy or ≥ 2 ng/ml more than the PSA nadir in patient following radiotherapy, as defined by the ASTRO-Phoenix criteria \[18\] and no evidence of malignancy on standard of care imaging for metastases (CT of the chest/abdomen/pelvis and bone scan) within 3 months.

Exclusion Criteria:

1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
2. Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
3. Change in therapy since standard of care imaging

Where it's running

• Hoag Memorial Hospital Presbyterian
  Irvine, California, United States Recruiting

Study contacts

• Study coordinator: Beth Thomsen
• Email: clinicalresearch@hoag.org
• Phone: 949-764-4577

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.