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PSMA PET For intermediate- or high-risk prostate cancer prior to RadioTherapY: A prospective interventional randomized clinical trial (P4RTY)
EU CTIS ID: 2023-506032-33-00
What this study is testing
To assess difference in efficacy between curative-intent RT based on PSMA PET vs based on standard-of care imaging, in patients with primary prostate cancer (intermediate- or high-risk) for whom curative-intent RT is appropriate given the imaging results.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- Extra-pelvic metastases (M1 disease) on any imaging or biopsy done before randomization.
- 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
- Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate
- 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
See the full eligibility criteria
Who can join
- 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.
What rules you out
- Extra-pelvic metastases (M1 disease) on any imaging or biopsy done before randomization.
- 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
- Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate
- 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
- 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)
- Concurrent or prior surgery or systemic therapy for prostate cancer
- Any kind of radiopharmaceutical within a period corresponding to 8 half-lives of the respective radionuclide
- 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
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant
- Prior PSMA PET
- Prior pelvic RT
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.