Using a new imaging technique to detect prostate cancer in high-risk patients
2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-Amino]-Pentyl}-Ureido)-Pentanedioic Acid (PyL) in Patients With High Risk and Biochemically Recurrent Prostate Cancer
This study is testing a new imaging method to see if it can help find prostate cancer spread in high-risk patients who might not show signs on regular scans.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Hoag Memorial Hospital Presbyterian Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT04700332 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with histologically confirmed adenocarcinoma of the prostate who are either high-risk or experiencing biochemical recurrence.
Not a fit: Patients with conditions that compromise safety or those unable to undergo PET/CT scanning due to weight limits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate detection of prostate cancer metastases, improving treatment planning and outcomes for patients.
How similar studies have performed: Other studies using novel PET tracers for prostate cancer detection have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Irvine, California
- Hoag Memorial Hospital Presbyterian — Irvine, California, United States (Recruiting)
Study contacts
- Study coordinator: Beth Thomsen
- Email: clinicalresearch@hoag.org
- Phone: 949-764-4577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.