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Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer.
EU CTIS ID: 2023-509881-39-00
What this study is testing
The primary aim is to study the effect of 177Lu-PSMA RLT in patients with oligo-metastatic, hormone sensitive metastatic PCa, by comparing the fraction of patients that have disease progression (as a surrogate for progression free survival) and meet EOT 1 criteria within 6 months in a group of patients that are treated with 177Lu-PSMA RLT and a group that follows the current standard of care (deferred androgen deprivation therapy).
- Therapeutic exploratory (Phase II)
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 with sufficient archived tumor material. This material has to be archived till study closure
- Laboratory values: • White blood cells > 3.0 x 109/l • Platelet count > 75 x 109/l • Hemoglobin > 6.2 mmol/l • ASAT, ALAT < 3 x ULN • MDRD-GFR ≥ 50 ml/min
- Signed informed consent
- Biochemical recurrence (PSA > 1.0 μg/l)
- PSA-doubling time < 6 months. Serum PSA progression is defined as 2 consecutive rising PSA values measured at least 1 week apart. The minimal start value is 0.2 μg/l
- 18F-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab): ≥1, maximally 5 metastases
You likely can't join if
- 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 affect patients’ clinical status when participating in this trial
- Prior hip replacement surgery potentially influencing performance of PSMA PET/CT
- Sjogren's syndrome
See the full eligibility criteria
- Histological proven adenocarcinoma of the prostate with sufficient archived tumor material. This material has to be archived till study closure
- Laboratory values: • White blood cells > 3.0 x 109/l • Platelet count > 75 x 109/l • Hemoglobin > 6.2 mmol/l • ASAT, ALAT < 3 x ULN • MDRD-GFR ≥ 50 ml/min
- Signed informed consent
- Biochemical recurrence (PSA > 1.0 μg/l)
- PSA-doubling time < 6 months. Serum PSA progression is defined as 2 consecutive rising PSA values measured at least 1 week apart. The minimal start value is 0.2 μg/l
- 18F-PSMA-PET-CT positive metastases in bones and/or lymph nodes (N1/M1ab): ≥1, maximally 5 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); testosterone > 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 6 months
- 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 >6 months
- 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 affect patients’ clinical status when participating in this trial
- Prior hip replacement surgery potentially influencing performance of PSMA PET/CT
- Sjogren's syndrome
- A second active malignancy other than prostate cancer
- Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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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.