Emerging digital imaging-guided theranostic therapy for newly diagnosed high risk prostate cancer patients: A feasibility study

Phase 1

Not yet recruiting

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12620001358932
• Lead Sponsor: I-MED Radiology Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-17
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Male
• Target Recruitment: 5

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival as assessed by recurrence of prostate cancer observed on digital PSMA positron emission tomography/computed tomography.[Up to 10 years following first LuPSMA treatment as per routine standard care under the care of their treating specialist.];Progression-free survival as assessed by change in serum prostate specific antigen level.[Up to 10 years following first LuPSMA treatment as per routine standard care under the care of their treating specialist.];Overall survival as determined by time lapsed between first LuPSMA treatment and date of death.[Up to 10 years following first LuPSMA treatment as per routine standard care under the care of their treating specialist.]

Secondary Outcome Measures

Name	Time	Method
Safety of LuPSMA treatment as assessed by monitoring adverse events as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.[During and following LuPSMA treatment for a maximum of 4 weeks post-treatment.]