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Trial Title:
Neoadjuvant PSMA-RLT in Oligometastatic PCa
NCT ID:
NCT06259123
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
[177Lu]Lu-PSMAI&T
Oligometastatic prostate cancer
Radical prostatectomy
Therapy toxicity
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Prospective single-center phase II study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[177Lu]Lu-PSMA I&T
Description:
2 cycles of 5 GBq [177Lu]Lu-PSMA I&T at 6-week intervals prior radical prostatectomy for
patients with oligometastatic prostate cancer
Arm group label:
Oligometastatic prostate cancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging
Other name:
PSMA-RLT
Summary:
Prospective single-center phase II study to evaluate the PSA, imaging and pathological
response, as well as oncological outcomes of systemic radioligand therapy
[177Lu]Lu-PSMAI&T (PSMA-RLT) in patients planned for radical prostatectomy (RP) for
oligometastatic prostate cancer (PCa) diagnosed using [68Ga]Ga-PSMA-11 PET examination.
Ten patients with oligometastatic primary PCa diagnosed using [68Ga]Ga-PSMA-11 PET-CT/MRI
imaging will be included in this study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x
109 /L and Haemoglobin ≥9 g/dL.
- 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.
- Patients must be able to sign Informed Consent Form
Exclusion Criteria:
- Concomitant participation in any other interventional trial
- Concurrent severe oncologic and medical conditions that result in patients not
having a life expectancy of longer than the duration of the trial.
- Nonmetastatic PCa on [68Ga]Ga-PSMA-11 imaging
- >5 osseous metastases on [68Ga]Ga-PSMA-11 imaging
- Visceral metastases, apart from lungs
- Age > 75 years.
- Ongoing or previous androgen deprivation therapy with agonist or antagonist
therapies.
- Presence of clinically relevant somatic or psychiatric diseases that might interfere
with the objectives and assessments of the study.
- Complete urinary out-flow obstruction or severe unmanageable urinary incontinence
Gender:
Male
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical University of Vienna
Address:
City:
Vienna
Zip:
1090
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Sazan Rasul, PhD
Phone:
004314040058742
Email:
sazan.rasul@meduniwien.ac.at
Contact backup:
Last name:
Shahrokh F. Shariat, Professor
Phone:
004314040026150
Email:
shahrokh.shariat@meduniwien.ac.at
Investigator:
Last name:
Sazan Rasul, PhD
Email:
Principal Investigator
Investigator:
Last name:
Pawel Rajwa, MD
Email:
Sub-Investigator
Start date:
February 1, 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Medical University of Vienna
Agency class:
Other
Source:
Medical University of Vienna
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06259123
