A FEASIBILITY STUDY OF 177LU-PSMA RADIOLIGAND THERAPY ALTERNATED WITH RADIUM-223 IN PATIENTS WITH BONE-METASTATIC, OLIGO-METASTATIC HORMONE-SENSITIVE PROSTATE CANCER AFTER CURATIVE THERAPY. THE DUET STUDY

• Conditions: bone metastatic prostate cancer; Metastatic prostate cancer; 10036958

• Registration Number: NL-OMON56209
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

- Histological proven adenocarcinoma of the prostate
- Previous radical prostatectomy
- Biochemical recurrence (PSA > 0.5 µg/l).
- PSA*doubling time < 6 months. Serum PSA progression is defined as 2
consecutive rising PSA
values measured at least 1 week apart.
- 18F*PSMA*PET*CT positive metastases in bones and/or lymph nodes
(miN1/miM1ab): Minimally 2 bone metastases, maximally 5 bone metastases.
- Local treatment for oligo*metastases with radiotherapy or surgery appears to
be no option
anymore (due to prior treatment or the location of the metastatic lesions or if
the patient refuse
these treatments).
- No prior hormonal therapy (including any androgen directed treatment such as
finasteride,
dutasteride, bicalutamide, apalutamide, abiraterone or enzalutamide) or taxane
based
chemotherapy (docetaxel or cabazitaxel);

Exception: local prostate cancer treated with local radiotherapy plus adjuvant
androgen deprivation therapy (ADT); these
patients need to be stopped with ADT at least 12 months.

- Testosterone > 1.7 nmol/l.
- A detectable lesion on the 18F*PSMA PET/CT with significant PSMA avidity,
defined by a SUVmax > 15 (partial volume corrected).
- ECOG 0*1
- Patients must have a life expectancy >12 months.
- Laboratory values:

• White blood cells > 4.0 x 109/l
• Platelet count > 150 x 109/l
• Hemoglobin > 7.0 mmol/l
• MDRD*GFR >= 60 ml/min

- Signed informed consent.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in
this study in case of:

- A known subtype other than prostate adenocarcinoma.
- Previous PSMA based radioligand treatment.
- Visceral or brain metastases.
- Any medical condition present that in the opinion of the investigator will
negatively affect patients* clinical
status when participating in this trial.
- Prior hip replacement surgery potentially influencing performance of PSMA
PET/CT.
- Sjögrens syndrome
- A second active malignancy other than prostate cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to assess the feasibility and safety of<br /><br>drug application in patients with low volume, hormone sensitive bone metastatic<br /><br>prostate cancer treated by Radium-223 radioligand therapy (RLT) and 177Lu-PSMA<br /><br>RLT.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p><br /><br>-Toxicity and (Serious) adverse events will be monitored and reported in<br /><br>concordance with the NCI Common Terminology Criteria for Adverse Events (CTCAE<br /><br>v5.0).<br /><br><br /><br>-An assessment of the Quality-of-Life (QoL), using patient reported outcome<br /><br>measurements (PROMS) and specific QoL questionnaires is performed. EORTC QLQ*<br /><br>C30, QLQ*PR25 & xerostomia inventory.<br /><br><br /><br>-PSA levels are registered on follow-up. The 3,6 and 12-months progression-free<br /><br>survival is recorded for each patient. </p><br>