Actively Recruiting
A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study
Led by Novartis Pharmaceuticals · Updated on 2025-12-31
106
Participants Needed
21
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).
CONDITIONS
Official Title
A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before joining the study
- Adults aged 18 years or older
- ECOG performance status of 0 or 1
- Histological confirmation of prostate adenocarcinoma
- PSMA-positive confirmed by 68Ga-PSMA PET/CT scan at baseline
- Castrate level of testosterone (< 50 ng/dL or < 1.7 nmol/L) by surgery or medication
- Progressed once on prior second generation androgen receptor pathway inhibitors
- Documented progressive metastatic castration-resistant prostate cancer
- At least one metastatic lesion visible on CT, MRI, or bone scan
- Kidney function with eGFR ≥ 60 mL/min/1.73m2 by CKD-EPI equation
- Recovered to Grade 2 or less from prior treatment toxicities except hair loss
You will not qualify if you...
- Received strontium 89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemi-body irradiation within 6 months
- Prior radioligand therapy
- Previous cytotoxic chemotherapy for metastatic prostate cancer (taxanes, platinum, estramustine, vincristine, methotrexate), immunotherapy, or biological therapy within 6 months (except allowed adjuvant/neoadjuvant taxane if >12 months ago and sipuleucel-T)
- Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitors, biological, or investigational treatments
- Heart attack, angina, or coronary artery bypass surgery within 6 months or significant active heart disease
- Serious acute or chronic kidney disease or moderate to severe renal impairment
- Other active cancers expected to affect life expectancy or disease assessment
- Sexually active males unwilling to use condoms during study and for 14 weeks after
- Urinary blockage or uncontrollable urinary incontinence
- Psychiatric or somatic conditions interfering with study aims or assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
University of California LA
Los Angeles, California, United States, 90095
Actively Recruiting
2
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
3
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Wash U School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
6
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
7
Novartis Investigative Site
Wuppertal, North Rhine-Westphalia, Germany, 42283
Actively Recruiting
8
Novartis Investigative Site
Aachen, Germany, 52074
Actively Recruiting
9
Novartis Investigative Site
Berlin, Germany, 13353
Actively Recruiting
10
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
11
Novartis Investigative Site
München, Germany, 80377
Actively Recruiting
12
Novartis Investigative Site
Rostock, Germany, 18057
Actively Recruiting
13
Novartis Investigative Site
Nijmegen, Gelderland, Netherlands, 6500HB
Actively Recruiting
14
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
Actively Recruiting
15
Novartis Investigative Site
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
16
Novartis Investigative Site
Barcelona, Spain, 08041
Actively Recruiting
17
Novartis Investigative Site
Bellinzona, Switzerland, 6500
Actively Recruiting
18
Novartis Investigative Site
Bern, Switzerland, 3010
Actively Recruiting
19
Novartis Investigative Site
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
20
Novartis Investigative Site
Birmingham, West Midlands, United Kingdom, B15 2TH
Actively Recruiting
21
Novartis Investigative Site
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
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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