NCT04700332 PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer
| NCT ID | NCT04700332 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hoag Memorial Hospital Presbyterian |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2022-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 184 participants in total. It began in 2021-02-01 with a primary completion date of 2022-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Deborah Fridman, PsyD, RN
STUDY DIRECTOR
Hoag Memorial Hospital Presbyterian
Frequently Asked Questions
Who can join the NCT04700332 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04700332 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04700332 currently recruiting?
Yes, NCT04700332 is actively recruiting participants. Contact the research team at clinicalresearch@hoag.org for enrollment information.
Where is the NCT04700332 trial being conducted?
This trial is being conducted at Irvine, United States.
Who is sponsoring the NCT04700332 clinical trial?
NCT04700332 is sponsored by Hoag Memorial Hospital Presbyterian. The principal investigator is Deborah Fridman, PsyD, RN at Hoag Memorial Hospital Presbyterian. The trial plans to enroll 184 participants.
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