Evaluating PSMA-PET/CT for Prostate Cancer Recurrence
Prostate-Specific Membrane Antigen (PSMA) Guided Approach for bIoCHEmical Relapse After Prostatectomy- A Prospective Observational Study-PSICHE
This study is testing if using a special imaging technique called PSMA-PET/CT can help guide better treatment for men with prostate cancer who have had a rise in their PSA levels after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Azienda Ospedaliero-Universitaria Careggi Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Florence) |
| Trial ID | NCT05022914 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess progression-free survival in patients experiencing biochemical relapse after radical prostatectomy, utilizing a PSMA-PET/CT guided treatment approach. Participants will undergo centralized 68Ga-PSMA PET/CT imaging to determine the appropriate salvage treatment based on the findings. The study includes patients with prostate adenocarcinoma who have a specific PSA level at recurrence, and treatment options will vary depending on the imaging results. The approach includes various radiation therapy options and systemic therapies tailored to the patient's condition.
Who should consider this trial
Good fit: Ideal candidates are men over 18 who have undergone radical prostatectomy for prostate adenocarcinoma and are experiencing biochemical relapse with a PSA level between 0.2 and 1 ng/ml.
Not a fit: Patients who have received androgen deprivation therapy within the last 6 months or have persistent PSA elevation shortly after surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with recurrent prostate cancer after surgery.
How similar studies have performed: Other studies utilizing PSMA-PET/CT for treatment guidance in prostate cancer have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * Age \>18 * Patient suitable for 68Ga-PSMA PET/CT re-staging according to clinical practice (Previous radical prostatectomy with histological result of Prostate adenocarcinoma +/- postoperative prostate bed radiotherapy (adjuvant or salvage setting), with a biochemical relapse defined as a PSA \> 0.2 and \<1 Exclusion Criteria: * ADT administration within 6 months from study enrollment * Persistent elevation of PSA after RP measured within 16 weeks from surgery (\> 0.1 ng/ml)
Where this trial is running
Florence
- AOU Careggi Radiation Oncology Unit — Florence, Italy (Recruiting)
Study contacts
- Principal investigator: Lorenzo Livi, Prof. — Azienda Ospedaliero-Universitaria Careggi
- Study coordinator: Lorenzo Livi, Prof.
- Email: lorenzo.livi@unifi.it
- Phone: +390557947264
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.