NCT04700332RecruitingPhase 2
PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer
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
Source: ClinicalTrials.gov · Last updated 27 Jul 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The standard of care imaging of prostate cancer metastases recommended by the National Comprehensive Cancer Network (NCCN), CT of the chest/abdomen/pelvis and bone scan, may be suboptimal. PyL is a novel PET tracer designed to detect prostate specific membrane antigen (PSMA) expressed on prostate cancer cells. PyL PET/CT may provide improved evaluation of clinically significant metastases in patients with prostate cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 184 (estimated)
- First submitted
- 4 Jan 2021
- Start date
- 1 Feb 2021
- Primary completion date
- 15 Jul 2022
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Diseases
- Prostate cancer
- NCT number
- NCT04700332
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 184
- From 1 Feb 2021 to the primary completion date, 15 Jul 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in therapy since standard of care imaging
Other illness
- 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.
Other
- 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.
Who the study is looking for
- Male ≥ 18 years of age.
- Histologically confirmed adenocarcinoma of the prostate
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hoag Memorial Hospital Presbyterian Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.