None listed
Conditions
Brief summary
This study is investigating the safety, progression-free survival and overall survival of Lutetium-177 (Lu) prostate-specific membrane antigen (PSMA) radioligand therapy for the treatment of newly diagnosed high-risk prostate cancer patients. Who is it for? You may be eligible to participate in this study if you are aged 18 years or older, have been recently diagnosed with prostate cancer (localised to the prostate) and are scheduled to be treated with surgery (prostatectomy). Study details Participants enrolled in this study will undergo a digital Gallium-68 PSMA positron emission tomography/computed tomography (PET/CT), imaging of the body to ensure cancer is localised to the prostate. Participants will then receive one dose of LuPSMA by intravenous infusion 1-2 weeks prior to scheduled prostatectomy. Then 7-9 weeks following surgery, patients will undergo another LuPSMA treatment. It is hoped that this research will determine that LuPSMA is safe and effective as an adjunct to surgery in treatment of patients with high-risk prostate cancer and can improve outcomes for future patients.
Interventions
This study will involve performing Lutetium-177 (177Lu)-prostate-specific membrane antigen (LuPSMA) treatment as an adjunct to standard care (prostatectomy) in patients with newly diagnosed high-risk PSMA-expressing prostate cancer.
LuPSMA is a novel and highly targeted systemic radioligand therapy for progressive metastatic castration-resistant prostate cancer.
Patients will undergo one LuPSMA treatment 8.0–9.0 +/- 10% GBq activity administered
via a dedicated radionuclide therapy pump (RadInje
This study will involve performing Lutetium-177 (177Lu)-prostate-specific membrane antigen (LuPSMA) treatment as an adjunct to standard care (prostatectomy) in patients with newly diagnosed high-risk PSMA-expressing prostate cancer. LuPSMA is a novel and highly targeted systemic radioligand therapy for progressive metastatic castration-resistant prostate cancer. Patients will undergo one LuPSMA treatment 8.0–9.0 +/- 10% GBq activity administered via a dedicated radionuclide therapy pump (RadInject, Tema Sinergie, Italy) over 10 minutes under the supervision of a Nuclear Medicine Radiologist and a Technologist. This is followed by prostatectomy surgery within 1-2 weeks after LuPSMA treatment. Patients will undergo a second dose of LuPSMA treatment 8-10 weeks after prostatectomy. Patients will undergo two, single doses of LuPSMA in total by intravenous infusion.
Sponsors
I-MED Radiology Network
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Newly diagnosed high-risk prostate-specific membrane antigen (PSMA)-expressing prostate cancer defined as International Society of Urological Pathologists grade of 5 or Gleason score of 9 or 10, and a minimum standard uptake value of 10 on digital Gallium-68 (Ga68)-PSMA positron emission tomography/computed tomography (PET/CT). Patient must be scheduled for a prostatectomy with a Wesley surgeon. Other inclusion criteria is standard for this treatment at our site. Inclusive of: • Referrals for LuPSMA therapy are accepted from Medical Oncologists, Radiation Oncologists or Urologists. On referral, each patient is discussed at a multi-disciplinary team meeting to ensure that there is consensus on the appropriateness of LuPSMA therapy. • To confirm suitability for treatment, a Ga68-PSMA PET/CT with diagnostic-quality CT demonstrating PSMA-avid disease is required. • Laboratory tests are required to demonstrate; (i) baseline serum prostate-specific antigen (PSA) level, (ii) a full blood count showing acceptable haemoglobin (at least 90 g/L), neutrophil (at least 1.5 x 10^9/L) and platelet (at least 75 x 10^9/L) values, (iii) renal function without impairment (estimated glomerular filtration rate (eGFR) at least 40 mL/min), and (iv) liver function without impairment (albumin at least 25 g/L). Laboratory test results are used as a guide only, with exceptions made on a case-by-case basis. • A nuclear medicine renal scan with technetium-99 m mercaptoacetyltriglycine (99mTc-MAG3) is required if there is evidence of renal obstruction or impairment on the diagnostic-CT component of the Ga68-PSMA PET/CT or eGFR test.
Exclusion criteria
Any disease outside the prostate on digital PSMA PET/CT.
Outcome results
None listed