PSMA PET/CT Guided Intensification of Therapy in Patients at Risk of Advanced Prostate Cancer

Through the conduct of a Phase III randomized controlled trial, investigators plan to: 1) determine if PSMA PET/CT guided intensification of radiotherapy or surgery improves cancer outcomes compared to conventional imaging-guided therapy in patients at risk of advanced disease, 2) evaluate its impact on toxicity and quality of life, and 3) measure the cost-effectiveness of the PSMA PET/CT guided approach. Participants with high-risk prostate cancer planned for curative-intent standard-of-care radiotherapy or surgery, or with biochemical failure after radical prostatectomy planned for salvage radiotherapy will be enrolled over 3 years (n=776). Those randomized to the investigational arm will have PSMA PET/CT prior to therapy. Based on the imaging results, treating physicians will intensify radiotherapy or surgery unless widely metastatic disease is found, in which case systemic therapy will be intensified.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

* Histological diagnosis of adenocarcinoma of the prostate planned for curative-intent standard-of-care radiotherapy (primary or salvage post prostatectomy) or radical prostatectomy with lymph node dissection.
* Age ≥ 18
* High risk of regional or distant metastases as defined by any of:
* Newly diagnosed and untreated prostate cancer with CAPRA score 6-10, or stage cN1.
* Prior history of radical prostatectomy and biochemical failure (PSA\>0.1ng/mL).
* Patients must provide study-specific informed consent prior to study entry.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

* Active or prior androgen deprivation therapy (except 5-alpha reductase inhibitor) terminated \< 12 months prior to enrollment.
* Prior or planned PSMA PET/CT scan outside of this clinical trial.
* Charlson Comorbidity Index \> 5 (see Appendix 2).
* Prior curative intent treatment for prostate cancer with local therapy other than surgery (primary radiotherapy or ablative therapies)
* Evidence of extra-pelvic nodal disease (M1a) on conventional imaging (if performed)
* Evidence of metastatic disease (M1b bone, M1c viscera/soft tissue) on conventional imaging (if performed)

• DERIVEDMenard C, Young S, Zukotynski K, Hamilton RJ, Benard F, Yip S, McCabe C, Saad F, Brundage M, Nitulescu R, Bauman G. PSMA PET/CT guided intensification of therapy in patients at risk of advanced prostate cancer (PATRON): a pragmatic phase III randomized controlled trial. BMC Cancer. 2022 Mar 8;22(1):251. doi: 10.1186/s12885-022-09283-z. PMID 35260100