Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate Cancer

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: Male

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-specific membrane antigen (PSMA), which is overexpressed in prostate cancer cells. In the last few years, several lutetium-177 (177Lu, β emitter) labeled PSMA ligands have been developed and are currently applied to treat metastatic castrate resistant prostate cancer patients. To date, there are no prospective randomized studies published using this treatment in the hormone sensitive setting or in oligometastatic prostate cancer. Therefore, this study we will evaluate the effect of 177Lu-PSMA in patients with hormone sensitive oligo-metastatic prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborators: Advanced Accelerator Applications; Prostaatkankerstichting
• Treatments: 177Lu-PSMA-617

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.