Clinical trial Recruiting at 1 site Observational Ages 18 and up Men only

Evaluating PSMA-PET/CT for Prostate Cancer Recurrence

Official title: Prostate-Specific Membrane Antigen (PSMA) Guided Approach for bIoCHEmical Relapse After Prostatectomy- A Prospective Observational Study-PSICHE

Run by Azienda Ospedaliero-Universitaria Careggi · NCT05022914 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexMen only
Enrollment180 (estimated)
SponsorAzienda Ospedaliero-Universitaria Careggi
Academic / other
Drugs / interventionsradiation
Locations1 site (Florence)
StatusRecruiting
StartedJanuary 19, 2021
Main results expectedJanuary 19, 2024
Study endsJanuary 19, 2027
Registry record updatedAugust 26, 2021
Trial IDNCT05022914 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies utilizing PSMA-PET/CT for treatment guidance in prostate cancer have shown promising results, indicating potential success for this approach.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.