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

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 - DUET trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56209

Enrollment

Registered

2023-10-05

Start date

2024-09-01

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bone metastatic prostate cancer Metastatic prostate cancer

Interventions

After screening and baseline imaging with 18F-PSMA PET/ diagnostic CT without intravenous contrast, patients will be enrolled. Signed informed consent will be obtained. A baseline bone scintigraphy

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Histological proven adenocarcinoma of the prostate - Previous radical prostatectomy - Biochemical recurrence (PSA > 0.5 µg/l). - PSA*doubling time 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

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.

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)