Pilot study to evaluate dosimetry and toxicity of lutetium-177-PSMA-617 radioligand therapy in low volume, hormone sensitive metastatic prostate cancer

Completed

Conditions: prostate cancer
Prostate carcinoma
10038364
10036958

Registration Number: NL-OMON46596

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To calculate the doses delivered by Lutetium-177-PSMA-617 radioligand therapy<br /><br>in patients with low volume, hormone sensitive metastatic prostate cancer<br /><br>- To determine the toxicity (focusing on radiation doses to organs at risk) of<br /><br>Lutetium-177-PSMA-617 radioligand therapy in patients with low volume, hormone<br /><br>sensitive metastatic prostate cancer</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To evaluate the clinical efficacy of multiple doses Lutetium-177-PSMA-617<br /><br>radioligand therapy in patients with low volume, hormone sensitive metastatic<br /><br>prostate cancer by:<br /><br>1. the changes in PSA values after Lutetium-177-PSMA-617 RLT<br /><br>2. the changes on uptake of Gallium-68-PSMA-617 PET/CT before and 6<br /><br>months after Lutetium-177-PSMA-617 RLT<br /><br>3.To evaluate the changes in number and size of metastatic lymph nodes<br /><br>on nano-MRI before and 3 months after Lutetium-177-PSMA-617 RLT)<br /><br>- To evaluate the quality of life after Lutetium-177-PSMA-617 RLT<br /><br></p><br>