GOZETOTIDE for Prostate cancer

Inclusion criteria

• {"criterion_text":"- Male"}
• {"criterion_text":"- The participant must agree not to donate sperm for the purpose of reproduction until 24 hours following the dose of study intervention"}
• {"criterion_text":"- 18 years of age or older"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Histopathology-confirmed adenocarcinoma of the prostate."}
• {"criterion_text":"- Intermediate- to high-risk disease (PSA>10ng/mL, cT-stage≥2b, Gleason score≥7 or Decipher Score ≥0.45)"}
• {"criterion_text":"- Willingness to undergo radiotherapy."}
• {"criterion_text":"- Treating radiation oncologist intends to incorporate PSMA PET findings into the radiotherapy plan, if patient undergoes PSMA PET (arm 2)"}
• {"criterion_text":"- Eastern Cooperative Oncology Group Performance Status Grade 0 or 1."}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- Extra-pelvic metastases (M1 disease) on any imaging or biopsy done before randomization."}
• {"criterion_text":"- Active malignancies (i.e., Progressing or requiring treatment change in the last 24 months) other than disease being treated under study. Allowed exceptions [...]"}
• {"criterion_text":"- Contraindications to radiotherapy (including active inflammatory bowel disease)"}
• {"criterion_text":"- Concurrent or prior surgery or systemic therapy for prostate cancer"}
• {"criterion_text":"- Any kind of radiopharmaceutical within a period corresponding to 8 half-lives of the respective radionuclide"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant"}
• {"criterion_text":"- Prior PSMA PET"}
• {"criterion_text":"- Prior pelvic RT"}
• {"criterion_text":"- Previous treatment with ADT for prostate cancer"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Use of 5-alpha-reductase inhibitor ≤4 weeks prior to randomization"}
• {"criterion_text":"- Prior chemotherapy for prostate cancer"}
• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- Progression-free survival (PFS), defined as time from initiation of RT to -\tbiochemical recurrence defined as a rise by 2 ng/mL or more above the nadir PSA (defined as the lowest PSA achieved) after radiotherapy with or without short-term hormonal therapy [71] -\tappearance of metastases or loco-regional recurrence as defined below -\tdeath from any cause whichever occurs first","definition_or_measurement_approach":"Time from initiation of radiotherapy (RT) to first occurrence of any of: biochemical recurrence (rise by ≥2 ng/mL above nadir PSA after RT with/without short-term hormonal therapy), appearance of metastases or loco-regional recurrence (as defined in protocol), or death from any cause."}

Secondary endpoints

• {"endpoint_text":"- Change in initial treatment intent","definition_or_measurement_approach":"Assessment of whether initial treatment intent changes after imaging (PSMA PET vs standard-of-care)."}
• {"endpoint_text":"- Metastasis-free survival (MFS), defined as time from initiation of RT to occurrence of new metastases defined as -\tPET or radiographic bone or soft tissue distant metastases by blinded independent central review* -\tpathologic finding of distant metastases -\tdeath from any cause whichever occurs first","definition_or_measurement_approach":"Time from initiation of RT to first occurrence of PET or radiographic distant metastases confirmed by blinded independent central review, pathologic finding of distant metastases, or death from any cause."}
• {"endpoint_text":"- Loco-regional control (pelvis) Occurrence of loco-regional progression defined as (whichever occurs first): -\tPET or radiographic pelvic non-bone PCa lesions by blinded independent central review* -\tPathologic finding of pelvic non-bone PCa lesions","definition_or_measurement_approach":"Occurrence of pelvic non-bone prostate cancer lesions detected by PET or radiographic imaging confirmed by blinded independent central review, or pathologic confirmation."}
• {"endpoint_text":"- Overall survival (OS), defined as time from initiation of RT to death from any cause.","definition_or_measurement_approach":"Time from initiation of RT to death from any cause."}
• {"endpoint_text":"- Post-salvage bPFS - In patients without salvage therapy: Time from initiation of RT until progression as defined above (primary endpoint) - In patients with salvage therapy: Time from initiation of RT until progression post-salvage therapy as defined above (primary endpoint) *Following the joint EAU ESUR ESTRO SIOG 2018 guideline, Section 6.3.4.4","definition_or_measurement_approach":"Time from initiation of RT until progression per primary endpoint definition; for patients receiving salvage therapy, time until progression after salvage therapy per primary endpoint definition."}
• {"endpoint_text":"- Safety endpoints: Adverse events of CTC grade ≥3 and serious adverse events (SAE) according to the NCI Common Terminology Criteria for Adverse Events (CTCAE, v5.0, 2017).","definition_or_measurement_approach":"Recording and grading of adverse events (AEs) and serious adverse events (SAEs) using NCI CTCAE v5.0; counts and rates of events grade ≥3 and SAEs."}

Germany

Earliest CTIS Part Ii Submission Date

22-05-2025

Latest Decision Or Authorization Date

04-07-2025

Processing Time Days

43

Number Of Sites

1

Number Of Participants

352

Primary sponsor

Full Name

Universitaetsklinikum Essen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Third parties

• {"country":"","full_name":"Deutsche Krebshilfe","duties_or_roles":"Source of monetary support","organisation_type":""}