utetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer.

Phase 2

Recruiting

Conditions: Adenocarcinoma of the prostate
prostate cancer
10027655
10036958

Registration Number: NL-OMON52656

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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 10^9/l
• Platelet count > 75 x 10^9/l
• Hemoglobin > 6.2 mmol/l
• ASAT, ALAT < 3 x ULN
• MDRD-GFR >= 50 ml/min
- Signed informed consent.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main goal of this study is to assess the difference in the fraction of<br /><br>patients that have disease progression during the 6 month follow up of this<br /><br>study after 177Lu-PSMA RLT or a deferred androgen deprivation treatment<br /><br>schedule. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints will be the ADT free survival, PSA response, toxicity<br /><br>defined by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0),<br /><br>radiological state of the disease expressed in the difference in amount and<br /><br>size of suspicious nodes 18F-PSMA PET/CT and (whole body) MRI between pre- and<br /><br>post-therapy and quality of life assessments.</p><br>