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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.
EU CTIS ID: 2024-518985-29-02
What this study is testing
The primary objective of this study is to assess the feasibility and safety of drug application in patients with bone metastatic, oligometastatic, hormone sensitive prostate cancer after curative therapy treated by Radium-223 radioligand therapy (RLT) alternated with 177Lu-PSMA RLT.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histological proven adenocarcinoma of the prostate
- ECOG 0‐1
- Patients must have a life expectancy >12 months
- Laboratory values (at baseline within 4 weeks before start of therapy ): • 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.
- Previous curative therapy with a radical prostatectomy or external-beam radiotherapy (EBRT)
You likely can't join if
- A known subtype other than prostate adenocarcinoma
- Previous radioligand treatment
- Visceral (liver/lung) or brain metastases
- Any medical condition 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
See the full eligibility criteria
- Histological proven adenocarcinoma of the prostate
- ECOG 0‐1
- Patients must have a life expectancy >12 months
- Laboratory values (at baseline within 4 weeks before start of therapy ): • 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.
- Previous curative therapy with a radical prostatectomy or external-beam radiotherapy (EBRT)
- Biochemical recurrence
- Serum PSA progression
- PSMA expressing metastases on an 18F‐PSMA‐PET‐CT scan: bone (and/or lymph node metastases) (miN1/miM1ab): minimally 1 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 refuses these treatments)
- No prior hormonal therapy (including any androgen directed treatment such as finasteride, dutasteride, bicalutamide, apalutamide, abiraterone, enzalutamide, and darolutamide) or taxane based chemotherapy (docetaxel or cabazitaxel)
- Testosterone > 1.7 nmol/l (at baseline within 4 weeks before start of therapy)
- A detectable lesion on the 18F‐PSMA PET/CT (at baseline within 4 weeks before start of therapy)
- A known subtype other than prostate adenocarcinoma
- Previous radioligand treatment
- Visceral (liver/lung) or brain metastases
- Any medical condition 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.