PSMA PET For intermediate- or high-risk prostate cancer prior to RadioTherapY: A prospective interventional randomized clinical trial (P4RTY)

Prior treatment

• Previous treatment with ADT for prostate cancer
• Prior treatment with a CYP17 inhibitor (e.g., oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any AR antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy
• Any of the following within 6 months prior to the trial intervention: severe or unstable angina, myocardial infarction, pulmonary embolism, stroke, clinically significant ventricular arrhythmias or NYHA Class II to VI heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
• Use of 5-alpha-reductase inhibitor ≤4 weeks prior to randomization
• Prior chemotherapy for prostate cancer
• Concurrent or prior surgery or systemic therapy for prostate cancer
• Any other investigational medicinal product within 2 days or within 5 times the elimination half-life of the respective investigational product prior receiving study intervention
• Prior PSMA PET
• Prior pelvic RT

Other illness

• Extra-pelvic metastases (M1 disease) on any imaging or biopsy done before randomization.
• Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 of the SmPC of 68Ga-PSMA-11 or to any of the components of the labelled radiopharmaceutical
• Active malignancies (i.e., Progressing or requiring treatment change in the last 24 months) other than disease being treated under study. Allowed exceptions [...]
• Contraindications to radiotherapy (including active inflammatory bowel disease)
• Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant

Other

• Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate
• Any kind of radiopharmaceutical within a period corresponding to 8 half-lives of the respective radionuclide

• Male
• The participant must agree not to donate sperm for the purpose of reproduction until 24 hours following the dose of study intervention
• 18 years of age or older
• Signed an informed consent form (ICF) indicating that the participant understands the purpose of, and the procedures required for the study and is willing to participate in the study: participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
• Histopathology-confirmed adenocarcinoma of the prostate.
• Intermediate- to high-risk disease (PSA>10ng/mL, cT-stage≥2b, Gleason score≥7 or Decipher Score ≥0.45)
• Willingness to undergo radiotherapy.
• Treating radiation oncologist intends to incorporate PSMA PET findings into the radiotherapy plan, if patient undergoes PSMA PET (arm 2)
• Eastern Cooperative Oncology Group Performance Status Grade 0 or 1.
• The participant must wear a condom when engaging in any sexual activity that allows the passage of ejaculate to another person while on study intervention, and for 24 hours following the dose of study intervention. Participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak.