Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this study is to assess the biochemical progression free survival (bPFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.

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

Details

• Lead Sponsor: Peter MacCallum Cancer Centre, Australia
• Collaborator: Varian Medical Systems

Criteria

Inclusion Criteria:

1. Male aged 18 years or older at screening

2. Patient has provided written informed consent

3. Histologically confirmed prostate adenocarcinoma with prior definitive surgical or radiotherapy treatment

4. Prior definitive treatment of the primary with either curative intent radiotherapy or surgery, with no evidence of PSMA avid disease in the prostate/prostate bed

5. Assessed as suitable for SABR with 1-5 sites of nodal or bony metastases on PSMA PET/computed tomography (CT). If nodal disease only, then at least one site of extra-pelvic nodal disease, defined as located above the bifurcation of the common iliac arteries

6. At least one site of disease with SUVmax twice the SUVmax of liver on PSMA PET (Ga-68 PSMA 11 or F-18 DCFPYL tracers only)

7. Adequate haematological function as defined by:

• Absolute neutrophil count (ANC) ≥1.5 x 109/L

• Platelet count >150x 109/L

• Haemoglobin ≥100 g/L

• Creatinine Clearance ≥ 40mL/min (Cockcroft-Gault formula)

8. Have a performance status of 0-1 on the Eastern Co-operative Oncology Group (ECOG) Performance Scale (see Appendix 1)

9. Patients must agree to use an adequate method of contraception

10. Patients must be willing and able to comply with all study requirements, including all treatments and required scheduled assessments

Exclusion Criteria:

1. Small cell or neuroendocrine differentiation of prostate cancer

2. Prior systemic therapy, radiation therapy, or surgery for metastatic prostate cancer. Prior ADT is allowed but ADT within six months of screening for the study is not allowed If patients have received prior ADT, serum testosterone levels must be above the lower limit of normal

3. No sites of PSMA negative metastatic disease evident on CT/bone scan

4. Any visceral (AJCCC M1c) metastases

5. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression

6. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator

7. Prior diagnosis of another cancer within 3 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma, adequately treated papillary thyroid carcinoma or adequately treated non-muscle invasive bladder cancer (Tis, Ta and low grade T1 tumours)