KEY TAKEAWAYS
- The PSICHE trial aimed to evaluate the efficacy of a PSMA-guided approach for managing post-prostatectomy biochemical relapse.
- PSMA-targeted treatment approach showed promise, with most patients avoiding ADT and associated toxicity.
Radical prostatectomy is a common treatment for prostate cancer. However, a significant number of patients experience a rise in prostate-specific antigen (PSA) levels after surgery, indicating a biochemical relapse. Traditional imaging methods for prostate cancer recurrence can be limited.
Salvage radiotherapy stands as a cornerstone in managing biochemical relapse post-radical prostatectomy. With the rising utilization of prostate-specific membrane antigen(PSMA)-PET/CT due to its enhanced diagnostic capabilities, treatment decision-making in this context has substantially transformed.
Giulio Francolini and the team aimed to unveil findings from the PSICHE trial, which assessed PSMA-guided management for post-prostatectomy biochemical relapse.
The study involved patients who had experienced biochemical recurrence after radical prostatectomy, with or without postoperative radiotherapy, and whose PSA levels ranged from 0.2 to 1 ng/ml. Each participant underwent staging utilizing 68Ga-PSMA PET/CT scans. Treatment pathways were determined based on the imaging outcomes.
For those with negative PSMA PET/CT results or prostate fossa-limited disease, prostate bed salvage radiotherapy was administered. Patients presenting with pelvic nodal recurrences or oligometastatic disease received stereotactic body radiotherapy (SBRT), while individuals with polymetastatic disease were directed toward androgen deprivation therapy (ADT).
Observation was recommended in cases where PSMA PET/CT scans were negative and postoperative radiotherapy had been previously performed. The chi-square test was utilized to analyze the correlation between baseline characteristics and the proportion of positive PSMA PET/CT scans.
About 174 patients were enrolled. The results revealed various outcomes, including 69.5% exhibiting negative results or prostate fossa-limited disease, 22.4% having pelvic nodal recurrences, 5.7% having oligometastatic disease, and 2.3% presenting with polymetastatic disease.
Based on these results, the recommended management strategies were determined. Salvage radiotherapy was advised for 59.8% of patients, while 28.2% were directed towards SBRT. Observation was recommended for 8.6% of cases, with immediate ADT initiated in 2.3% of patients. Additionally, 1.1% of participants were advised of re-treatment. These recommendations were tailored to the specific imaging findings to optimize patient management.
After a median follow-up period of 17 months, 50 cases exhibited subsequent biochemical progression post-treatment, of which 27 patients manifested interval distant metastases detected via PSMA. Subsequently, 13 patients commenced ADT. The median biochemical relapse-free survival was 25 months (95% CI: 20 – 63 months), while both metastases-free and ADT-free survivals were not reached.
The study concluded that within the framework of a prospective multicenter trial, employing a PSMA-adapted treatment approach yielded promising outcomes. A significant portion of patients maintained freedom from ADT, mitigating the risk of unnecessary treatment-related toxicity.
The trial was sponsored by the Azienda Ospedaliero-Universitaria Careggi.
Source: https://scientific-programme.uroweb.org/EAU24/programme
Clinical Trial: https://clinicaltrials.gov/study/NCT05022914
Francolini G., Di Cataldo V., Garlatti P., et al. (2024) “PSICHE trial (NCT05022914): PSMA guided approach for bIochemical relapse after prostatectomy- a prospective trial.” Presented at EAU 2024.
