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Trial Title:
PSMA-RLT in Biochemically Recurrent PCa
NCT ID:
NCT06220188
Condition:
Prostate Cancer Recurrent
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
[177Lu]Lu-PSMA I&T
PSMA-radioligand therapy
Biochemical recurrence
Prostate cancer
PSA value
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 one-arm phase II study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[177Lu]Lu-PSMA I&T
Description:
2 cycles (3 GBq in first cycle and 6 GBq in the second cycle) of [177Lu]Lu-PSMAI&T
radioligand therapy at 6-week intervals
Arm group label:
Biochemical recurrent prostate cancer but not radio-morphological local recurrence
Other name:
PSMA-RLT
Summary:
Prospective single-center one-arm phase II study in patients with prostate cancer and
confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng/ml after radical
prostatectomy (RP) or PSA > nadir + 2ng/ml after radiotherapy (RT) but not
radio-morphological local recurrence after primary therapy with curative intent receive
systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6
GBq in the second cycle) PSMA-RLT at 6-week intervals.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with biochemical recurrence after radical prostatectomy and radiotherapy
with a PSA doubling-time (DT) of ≤ 12 months.
- No hormonal therapy within the last 12 months or recovered testosterone levels.
- PSMA PET negative result for local recurrence; presence of distant metastases is
allowed: (cN0, cM0/cM1).
- 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 oncological and medical conditions that result in patients not
having a life expectancy of longer than one year.
- 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:
80 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:
014040058742
Email:
sazan.rasul@meduniwien.ac.at
Investigator:
Last name:
Sazan Rasul, PhD
Email:
Principal Investigator
Investigator:
Last name:
Pawel Rajwa, MD
Email:
Sub-Investigator
Start date:
January 15, 2024
Completion date:
January 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/NCT06220188
