Emerging digital prostate specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) guided Lutetium-177-PSMA therapy pre- and post-prostatectomy in newly diagnosed high risk prostate cancer patients: A feasibility study

I-MED Radiology Network0 sites5 target enrollmentDecember 17, 2020

ConditionsProstate Cancer Cancer - Prostate

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: I-MED Radiology Network
Enrollment: 5
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 17, 2020

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

I-MED Radiology Network

Eligibility Criteria

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.