Terbium 161 PSMA in Lutetium-177 PSMA Naive Patients

Sponsor
Ankara University
Study ID
NCT07441837
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Terbium 161- PSMA I&T — DRUG
    cycles of Tb-161 PSMA I\&T with 7.4 GBq activity

Study Details

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.

Key Dates

First listed
Mar 2, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Aug 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tb-161 PSMA treatment arm
    Patients who will treat with 3 cycles of Tb-161 PSMA with 7.4 GBq activity

Primary Outcome Measure

Objective response evaluation [ Time Frame: up to 6 weeks after last cycle of treatment (each cycle is 1 day) ]

Central Contacts

Find similar trials

Nationwide
Prostate cancer trialsOncology trialsProstate oncology trialsMen's health trialsUrology trials

Related Studies