Actively Recruiting
PSMA-RLT in Biochemically Recurrent PCa
Led by Medical University of Vienna · Updated on 2024-02-13
20
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PSMA-RLT in Biochemically Recurrent PCa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with biochemical recurrence after radical prostatectomy and radiotherapy with a PSA doubling-time of 4 months
- No hormonal therapy within the last 12 months or recovered testosterone levels
- PSMA PET negative result for local recurrence; distant metastases allowed (cN0, cM0/cM1)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Adequate bone marrow reserve: WBC 1.5 x 10^9/L, Platelets 100 x 10^9/L, Haemoglobin 9 g/dL
- Adequate renal function with eGFR 50 mL/min/1.73m2 and Albumin 2.5 g/dL
- Ability to sign Informed Consent Form
You will not qualify if you...
- Participation in any other interventional trial
- Severe oncological and medical conditions with life expectancy under one year
- Clinically relevant somatic or psychiatric diseases interfering with study objectives
- Complete urinary out-flow obstruction or severe unmanageable urinary incontinence
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
S
Sazan Rasul, PhD
CONTACT
S
Shahrokh F. Shariat, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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