PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE

  • End date
    Jan 19, 2027
  • participants needed
  • sponsor
    Azienda Ospedaliero-Universitaria Careggi
Updated on 5 September 2021


This observational study was designed to evaluate progression free survival after PSMA-PET/CT based salvage approach for patients affected by biochemical relapse after radical prostatectomy.


This is a prospective observational multicenter study including patients treated with upfront radical prostatectomy +/- postoperative prostate bed radiotherapy, with histological result of Prostate adenocarcinoma, affected by biochemical relapse (defined as PSA>/= 0.2 ng/ml) with a PSA at recurrence </=1 ng/ml. Patients will be staged with centralized 68 Ga- PSMA PET/CT and treated with a pre-defined approach based on 68 Ga-PSMA PET/CT findings.

The predefined approach will consist in the following flowchart:

  1. In negative 68Ga-PSMA PET/CT or positive findings within prostate bed: Prostate bed RT
  2. In 68Ga-PSMA PET/CT detecting pelvic nodal recurrence amenable with stereotactic body radiation therapy (SBRT) on all sites of disease: SBRT to all positive nodal disease.
  3. In abdominal nodal or bone oligometastatic disease amenable with stereotactic body radiation therapy (SBRT) on all sites of disease: SBRT on all sites of disease
  4. In abdominal nodal or bone metastatic disease (>3 lesions or non-amenable with SBRT) and/or visceral disease: ADT+/-other systemic therapies available for metastatic hormone sensitive pCa at physician discretion.

Condition Prostate Disorders, Non-metastatic Prostate Cancer, Prostatic disorder, Prostate Cancer Recurrent, Prostate Cancer, Malignant neoplasm of prostate, Prostate Cancer, Early, Recurrent, Prostate Adenocarcinoma, Adenocarcinoma of the Prostate, prostate cancers, prostate carcinoma, Recurrent Prostate Cancer, Adenocarcinoma of Prostate
Clinical Study IdentifierNCT05022914
SponsorAzienda Ospedaliero-Universitaria Careggi
Last Modified on5 September 2021


Yes No Not Sure

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note