Clinical trial • Phase II • Oncology
Gozetotide for Prostate cancer
Phase II trial of Gozetotide for Prostate cancer. 10 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Prostate cancer
- Trial Stage
- Phase II
- Drug Modality
- Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 07-11-2024
- First CTIS Authorization Date
- 14-01-2025
Trial design
Phase II trial across 1 site in Austria.
- Target Sample Size
- 10
- Trial Duration For Participant
- 200
Eligibility
Recruits 10 No vulnerable populations selected. Participants must be able to sign the Informed Consent Form; consent is provided by the adult participant. No assent or minor-consent procedures described..
- Vulnerable Population
- No vulnerable populations selected. Participants must be able to sign the Informed Consent Form; consent is provided by the adult participant. No assent or minor-consent procedures described.
Inclusion criteria
- {"criterion_text":"- Patients must be adults between 18 and 75 years of age.\n- Oligometastatic PCa diagnosed using [68Ga]Ga-PSMA-11 imaging defined as M1a and/or M1b positive with ≤5 osseous metastases and/or M1c ≤3 lung metastases\n- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n- Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL.\n- Patients must have adequate renal function with eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL.\n- Patients must be able to sign Informed Consent Form"}
Exclusion criteria
- {"criterion_text":"- Patients must be adults between 18 and 80 years of age.\n- Patients with BCR after RP and RT with a PSA doubling-time (DT) of ≤ 12 months.\n- No hormonal therapy within the last 12 months or recovered testosterone levels.\n- PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1).\n- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n- Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL.\n- Patients must have adequate renal function with eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL.\n- Patients must be able to sign Informed Consent Form."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Assess safety and toxicity of neoadjuvant PSMA-RLT and RP","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 10
- Recruitment Window Months
- 31
- Consent Approach
- Informed consent obtained from adult participants; participants must be able to sign the Informed Consent Form. Subject information and informed consent form document is listed in the CTIS documents. No assent or paediatric consent procedures described; languages not specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 10
Austria
- Earliest CTIS Part Ii Submission Date
- 19-11-2024
- Latest Decision Or Authorization Date
- 02-06-2025
- Processing Time Days
- 195
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Biomedical Imaging and Image-guided Therapy, Division of Nuclear Medicine
- Contact Person Name
- Sazan Rasul
- Contact Person Email
- sazan.rasul@meduniwien.ac.at
- Number Of Participants
- 10
Sponsor
Primary sponsor
- Full Name
- Medical University Of Vienna
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Austria
Investigational products
- Investigational Product Name
- Locametz 25 micrograms kit for radiopharmaceutical preparation
- Active Substance
- Gozetotide
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS BOLUS USE
- Route
- INTRAVENOUS BOLUS USE
- Authorisation Status
- Authorised (marketing authorisation EU/1/22/1692/001)
- Maximum Dose
- 259 MBq
- Investigational Product Name
- [177Lu]Lu-PSMA-I&T
- Active Substance
- Lutetium (177Lu) zadavotide guraxetan
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Investigational / sponsor product (no marketing authorisation listed)
- Maximum Dose
- 5.5 GBq (max daily dose)
- Investigational Product Name
- TECEOS Trockenstechampullen
- Active Substance
- Stannous oxide; 3,3-diphosphono-1,2-propanedicarboxylic acid, tetrasodium salt (DPD)
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS BOLUS USE
- Route
- INTRAVENOUS BOLUS USE
- Authorisation Status
- Authorised (marketing authorisation present: 4-00026)
- Maximum Dose
- 700 MBq
- Combination Treatment
- Yes
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