Status:
ACTIVE_NOT_RECRUITING
Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Prostaatkankerstichting
Advanced Accelerator Applications
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Radioligand therapy (RLT) using Lutetium-177 labelled PSMA is a promising new therapeutic approach to treat metastatic prostate cancer. This tumor-specific treatment is directed against prostate-speci...
Detailed Description
Prostate-specific membrane antigen (PSMA) radioligand therapy (RLT) is a promising new therapeutic approach to treat metastatic prostate cancer. This tumor-specific treatment is directed against PSMA,...
Eligibility Criteria
Inclusion
- Histological proven adenocarcinoma of the prostate with sufficient archived tumor material. This material has to be archived till study closure.
- 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.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04443062
Start Date
July 20 2020
End Date
January 1 2026
Last Update
October 30 2024
Active Locations (4)
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1
German Oncology Center
Limassol, Cyprus
2
Amsterdam UMC
Amsterdam, Netherlands
3
University Medical Center Groningen
Groningen, Netherlands
4
Radboud University
Nijmegen, Netherlands