Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients
ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorAnkara University
About this trial
In this study it is aimed to analyze the efficacy and safety of Tb-161 PSMA I\&T in the 7.4 GBq activity in a large patient group of Lu-177 PSMA naïve mCRPC patients. 3 cycles of Tb-161 PSMA will be administered with 6 weeks periods. After each cycle a triple bed quantitative single photon emission CT (SPECT)-CT scan from vertex to thigh will be acquired 24 h after every treatment of Tb-161 PSMA. In the first cycle additional time points SPECT-CT acquisitions will be obtained for dosimetric calculations. Details of dosimetry acquisitions will be provided by dosimetry partner. Routine safety blood tests including full blood counts, liver function test, electrolytes, serum PSA, and assessment for adverse events were performed every 3 weeks during study treatment. Once the patient completed three cycles of Tb-161 PSMA, they will continue to undergo clinical review, assessment for adverse events, routine safety bloods, and PSA every 6 weeks for 48 weeks. OR to treatment will be assessed by Ga-68 PSMA PET/CT using RECIP 1.0 criteria.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men aged 18 years or older with mCRPC (histologically or cytologically confirmed adenocarcinoma of the prostate)
Progressive disease as defined by the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) under previous treatment with taxane chemotherapy (unless medically unsuitable) and at least one second-generation androgen receptor pathway inhibitor (ARPI)
Adequate bone marrow, hepatic, and renal function
Eastern Cooperative Oncology Group performance status of 0-2;
Disqualifiers
Patients with discordant metastases defined as positive on 2-[¹⁸F]fluoro-2-deoxy-D-glucose (FDG) PET-CT with minimal uptake on Ga-68-PSMA PET-CT
Previous treatment with another radioisotope
Other malignancies within the previous 2 years before registration other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months
Concurrent illnesses that could jeopardise the ability of the patient to undergo the trial procedures.
Trial design
Design model
Single group
Treatments tested in this trial
Terbium 161- PSMA I&T
Drugcycles of Tb-161 PSMA I\&T with 7.4 GBq activity
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Tb-161 PSMA treatment armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response evaluation
Response to treatment will be assessed by Ga-68 PSMA PET/CT using RECIP 1.0 criteria.
Time frame
up to 6 weeks after last cycle of treatment (each cycle is 1 day)2
PSA response evaluation
At least 50% change in the serum PSA levels
Time frame
within three weeks after each treatment cycle and with 6 weeks periods from 6 to 48 weeks after last cycle (each cycle is 1 day)3
Change in QoL
Change in QoL will be evaluated by change in scores of the Functional Assessment of Cancer Therapy for Prostate (FACTP) questionnaire for treatment-specific symptoms.
Time frame
within 1 months after each cycles (each cycle is 1 day)4
Toxicity Evaluation
To analyze the organ toxicities of Tb-161 PSMA treatment with 7.4 GBq activity in 3 cycles with Common Terminology Criteria for Adverse Events (CTCAE) scores
Time frame
within three weeks after each treatment and with 6 weeks period within 6 to 48 weeks after last cycle (each cycle is 1 day)Secondary outcomes
1
Tumor absorbed dose calculations
To calculate the mean tumor absorbed doses in Gy with multi-frame SPECT/CT images with multi compartment model
Time frame
within 96 hours after first cycle (each cycle is 1 day)2
Organ absorbed dose calculations
To calculate the mean organ absorbed doses for salivary glands, kidney, liver and bone marrow in Gy with multi-frame SPECT/CT images
Time frame
within 96 hours after first cycle (each cycle is 1 day)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ankara University
Lead sponsor
Oncosia Scientific GmbH
Collaborator
EDH Nukleer Tip ve Saglik Hizmetleri Ltd. Sti.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: