Actively Recruiting
A Phase 2/3,PSMA-T4, Prostate Cancer
Led by NCBJ Polatom: Narodowe Centrum Badań Jądrowych Polatom · Updated on 2026-04-14
80
Participants Needed
4
Research Sites
190 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objectives of this study are to evaluate the feasibility and safety of \[99mTc\]Tc-PSMA-T4 in the diagnosis and treatment planning of prostate cancer.
CONDITIONS
Official Title
A Phase 2/3,PSMA-T4, Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Eastern Cooperative Oncology Group performance status less than 2
- Prior diagnosis of any type of prostate cancer with a Gleason score above 6
- Confirmatory prostate biopsy within 12 weeks before consent (for cohorts A and B only)
- Pelvic multiparametric MRI prostate with PIRADS 2.1 score within 12 weeks before screening (for cohorts A and B only)
- Willingness to participate and provide written informed consent
- Cohort A: Intermediate risk disease per National Comprehensive Cancer Network guidelines
- Cohort A: Greater than 10% chance of lymph node involvement by Memorial Sloan Kettering nomogram
- Cohort A: CT chest, abdomen, pelvis and bone scan within 12 weeks before screening in unfavorable risk subgroup
- Cohort A: No prior treatment for prostate cancer
- Cohort B: High or very high-risk disease per National Comprehensive Cancer Network guidelines
- Cohort B: CT chest, abdomen, pelvis and bone scan within 12 weeks before screening in unfavorable risk subgroup
- Cohort B: No prior treatment for prostate cancer
- Cohort C: Biochemical failure after radical prostatectomy or definitive radiotherapy or evidence of metastatic disease or symptoms suggesting distant metastases
You will not qualify if you...
- No histopathological confirmation of prostate cancer
- Presence of pacemakers or metal implants preventing pelvic MRI
- Abnormal liver function with liver enzymes greater than 5 times upper limit normal or bilirubin greater than 2 times upper limit normal
- Renal impairment with estimated glomerular filtration rate less than 30 ml/min
- Within 6 months before study: myocardial infarction, hospitalization for cardiac events, cerebrovascular accident, transient ischemic attack, stroke, pulmonary embolism, or deep vein thrombosis
- Acute congestive heart failure or severe arrhythmia, second or higher degree atrio-ventricular heart block
- Active infections deemed sufficient to exclude participation, including urinary tract, respiratory tract, and diabetic foot infections with osteomyelitis
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Centrum Onkologii im. prof. F. Łukaszczyka
Bydgoszcz, Poland, Poland, 85-796
Actively Recruiting
2
Centralny Szpital Kliniczny Uniwersytetu Medycznego
Lodz, Poland, Poland, 92-216
Actively Recruiting
3
GAMMED Centrum Diagnostyczno-Lecznicze
Warsaw, Poland, Poland, 02-351
Actively Recruiting
4
4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Wroclaw, Poland, Poland, 53-114
Completed
Research Team
P
Piotr Garnuszek, Sponsor
CONTACT
K
Katarzyna Socko, CRO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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