Compare and contrast of two prostate-specific membrane antigen (PSMA) PET tracer aids for detecting and staging prostate cancers.

Phase 2

Active, not recruiting

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12618000665235
• Lead Sponsor: Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-24
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

All patients:
1. Age equal to or greater than 60 years.
2. Patient has provided written informed consent for participation in this trial
3. The patient is able to comply with the required study procedures

Primary staging cohort:
1. Newly-diagnosed, untreated, biopsy proven adenocarcinoma of the prostate gland.
2. Patients must have at least one of the following features
- Gleason group 3, 4 or 5
- PSA >20 ng/mL within 12 weeks prior to referral
- Clinical stage =T3

Biochemical recurrence restaging cohort:
A. Prostatectomy cohort
1. Complete excision of the prostate gland, R0- or R1- resection
2. PSA =0.2ng/mL after nadir following radical prostatectomy

B. Radiotherapy cohort
1. Organ-preserving local treatment (external beam radiation therapy, brachytherapy, seed implantation, high intensity focused ultrasound)
2. PSA increase of 2.0ng/mL greater than the lowest recorded PSA value following therapy

Known metastatic disease restaging cohort:
1. Known distant metastatic prostate cancer (M1 a/b/c) diagnosed by at least one of the following:
- 68Ga-PSMA-11 demonstrating metastatic disease
- WBBS demonstrating lesions characteristic of prostate cancer metastases
- CT or MRI imaging demonstrating lesions characteristic of prostate cancer metastases
- Histological confirmation of prostate cancer metastasis

Exclusion Criteria

1. Significant intercurrent comorbidity that, in the opinion of the investigators, would limit compliance with the study protocol
2. Change in prostate cancer therapy after the 68Ga-PSMA-11 PET/CT but before the 18F-PSMA-1007 PET/CT.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the diagnostic performance of 18F-PSMA to 68Ga-PSMA for the detection of primary prostate cancer, local recurrence, regional nodal and distant metastatic prostate cancer[The detection of primary (T), pelvic nodal (N) or distant metastic (M) prostate cancer using PET/CT.]