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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 180 (estimated) |
| Sponsor | Azienda Ospedaliero-Universitaria Careggi Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Florence) |
| Status | Recruiting |
| Started | January 19, 2021 |
| Main results expected | January 19, 2024 |
| Study ends | January 19, 2027 |
| Registry record updated | August 26, 2021 |
| Trial ID | NCT05022914 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.
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Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy
This trial will test whether taking fezolinetant once daily for 4 weeks reduces how often and how severe hot flashes are in men with prostate cancer who are on androgen-deprivation therapy.
-
How social, structural, and lifestyle factors relate to prostate cancer outcomes in diverse men
This study looks at whether social and lifestyle factors help explain differences in prostate cancer outcomes among Black, Hispanic, and Asian men who have had a radical prostatectomy.
-
PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer
This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.
-
Lower-dose radiation to parts of the prostate for some men with prostate cancer
This study tests whether a smaller amount of radiation aimed at specific parts of the prostate can reduce side effects compared with giving the full prostate the same dose.
-
PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance
This study tries adding rhPSMA-7.3 (flotufolastat F18) PET/CT to standard mpMRI to see if it finds higher-grade prostate cancer in men on active surveillance.
-
Mini-tumors to guide treatment for aggressive prostate cancer
We will grow tiny, patient-derived mini-tumors in the lab to test which treatments work best for men with aggressive or metastatic prostate cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.