utetium-177-PSMA therapy in metastatic prostate cancer.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 58

Inclusion Criteria

- Histological proven adenocarcinoma of the prostate with archived
tumor material.
- Biochemical recurrence or clinical progression (PSA > 1.0 µg/l).
- ECOG 0-1.
- PSA-doubling time < 6 months.
- 18F-PSMA-PET-CT positive metastases in bones and/or lymph nodes
(N1/M1ab): =1, maximally 5 metastases .
- Local treatment for oligometastases with radiotherapy or surgery
appears to be no option anymore (due to prior treatment or the location
of the metastatic lesions).
- No prior hormonal therapy (including any androgen directed treatment
such as 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.
- No visceral metastases.
- 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43

Exclusion Criteria

- A detectable lesion on the 18F-PSMA PET/CT with significant PSMA
avidity, defined by a SUVmax > 10 (partial volume corrected).
- 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.