PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer

Launched by HOAG MEMORIAL HOSPITAL PRESBYTERIAN · Jan 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called PyL PET/CT to see if it can better detect prostate cancer spread in men who are at high risk or have had a recurrence of prostate cancer. Currently, standard imaging methods like CT scans and bone scans may not always provide a complete picture of the cancer. The trial aims to find out if PyL PET/CT can improve the detection of significant cancer spread, which can help doctors decide on the best treatment options.

To join the trial, participants need to be males aged 18 or older with confirmed prostate cancer. They should either have high-risk factors for the disease, such as a high PSA level or specific cancer characteristics, or have had a recurrence after treatment but no signs of metastasis on standard scans. Participants can expect to undergo the new imaging technique, which may help improve the way their cancer is monitored. It's also important to note that certain health conditions or weight restrictions may prevent some men from participating.

Gender

MALE

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