The aim of this study is to evaluate the dosimetry and toxicity of Lutetium-177-PSMA-617, in patients with low volume, hormone sensitive metastatic prostate cancer.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To calculate the doses delivered by Lutetium-177-PSMA-617 radioligand therapy
in patients with low volume, hormone sensitive metastatic prostate cancer
- To determine the toxicity (focusing on radiation doses to organs at risk) of
Lutetium-177-PSMA-617 radioligand therapy in patients with low volume, hormone
sensitive metastatic prostate cancer
Secondary outcome
- To evaluate the clinical efficacy of multiple doses Lutetium-177-PSMA-617
radioligand therapy in patients with low volume, hormone sensitive metastatic
prostate cancer by:
1. the changes in PSA values after Lutetium-177-PSMA-617 RLT
2. the changes on uptake of Gallium-68-PSMA-617 PET/CT before and 6
months after Lutetium-177-PSMA-617 RLT
3.To evaluate the changes in number and size of metastatic lymph nodes
on nano-MRI before and 3 months after Lutetium-177-PSMA-617 RLT)
- To evaluate the quality of life after Lutetium-177-PSMA-617 RLT
Background summary
Lutetium-177-PSMA-617 has been evaluated in end stage prostate cancer patients
extensively. Although the results of these studies are promising, all currently
available data are retrospective.
Interestingly, radioligand therapy is known to be more effective in low volume
disease in several tumor types, because of the very high tumor uptake of
radioligands in small lesions. This is the ratio for current prospective study:
radioligand therapy with Lutetium-177-PSMA-617 is possibly more effective in
low-volume disease. In this study, we will evaluate the dosimetry in small
volume disease. In future studies, efficacy will be assesed more extensively.
Study objective
The aim of this study is to evaluate the dosimetry and toxicity of
Lutetium-177-PSMA-617, in patients with low volume, hormone sensitive
metastatic prostate cancer.
Study design
Observational
Intervention
Infusion of Lutetium-177-PSMA-617
Study burden and risks
It is expected that treatment with Lutetium-177-PSMA-617 (first dose of 3 GBq
and second dose according to dosimetry results) will lead to transient
myelotoxicity and xerostomia.
In previous studies with high activity doses (~5.6 GBq), transient grade 3-4
myelotoxicity was observed in 12% of the participants. Transient xerostomia was
seen in 8% of the patients. In theory, nephrotoxicity is possible due to the
fact that the radioligand is cleared via the kidneys. However,no grade 3-4
nephrotoxicity was observed in previous studies. Because of de low activity
doses used in our study, the risk of nephrotoxicity is considered to be very
low.
In total, the hospital visits will take approximately 65 hours.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Histological proven adenocarcinoma of the prostate ;- Prior local therapy for prostate cancer;- Biochemical recurrence or clinical progression after local therapy (PSA > 0.2 µg/l), PSA-DT < 6 months);- 68Ga-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab): *1, maximally 10 metastases (minimal lesion size 1 cm to enable adequate dosimetry studies) ;- Local treatment for oligometastases with radiotherapy or surgery appears to be no option anymore (due to prior treatment or the location of the metastatic lesions);- No prior hormonal therapy or chemotherapy; testosteron > 1.7 nmol/l. ;Exception: local prostate cancer treated with local radiotherapy plus adjuvant ADT; these patients need to be stopped with ADT at least 3 months;- No visceral metastases ;- Laboratory values: ;* White blood cells * 3.5 x 10^9/l ;* Platelet count * 150 x 10^9/l ;* Hemoglobin * 6 mmol/l ;* ASAT, ALAT * 3 x ULN ;* MDRD-GFR * 60 ml/min ;-Signed informed consent
Exclusion criteria
- A known subtype other than prostate adenocarcinoma;- Any medical condition present that in the opinion of the investigator will affect patients* clinical status when participating in this trial. ;- Prior hip replacement surgery potentially influencing performance of PSMA PET/CT and nanoMRI;- Contra-indication for MRI imaging (claustrophobia, implanted electric and electronic devices (heart pacemakers, insulin pumps, implanted hearing aids, neurostimulators), intracranial metal clips, metallic bodies in the eye)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-003122-32-NL |
| CCMO | NL62774.091.17 |