68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer

• Status: Completed
• Trial end date: 2019-06-12
• Target enrollment: 0
• Participant gender: Male

Summary

This will be an open-labelled, single centre study in the UK. The study group will include 60 patients with three groups of patients being studied. Group A will consist of 20 patients who have been newly diagnosed with primary high risk prostate cancer and are scheduled for radical prostatectomy surgery. Group B will consist of 20 patients with a diagnosis of BCR with previous radical prostatectomy, and are being considered for radical salvage therapy. Group C will consist of 20 patients with a diagnosis of BCR with previous radical radiotherapy (but no surgery), and are being considered for radical salvage therapy.

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

Details

• Lead Sponsor: Theragnostics Ltd
• Collaborator: Theradex

Criteria

Inclusion Criteria:

Group A: Adenocarcinoma of the prostate gland suitable for radical Tx.

• Adenocarcinoma of Prostate

• Gleason score 4+3 and above, or PSA > 20 ng/mL or clinical stage >T2C.

• Suitable for surgical tx

• No Hormone Therapy in last 3 months

Group B: PCa and a diagnosis of BCR, previously treated with radical prostatectomy, being considered for radical salvage therapy (with curative intent).

• Original diagnosis of PCa, treated with radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR based on:

1. Post RP: two consecutive rises in PSA and final PSA >0.lng/ml OR Post RP: three consecutive rises in PSA. This definition is also applicable to subjects with PSA persistence post RP (where the PSA fails to fall to undetectable levels).

2. Post RP: PSA doubling time of ~15 months OR PSA level 0.5 ng/ml.

• No previous recurrences of PCa.

• Consideration for radical salvage therapy.

• Should not have received androgen-deprivation therapy within 3 months of screening.

• No Hormone Therapy in last 3 months

Group C: PCa and a diagnosis of BCR, previously treated with radical radiotherapy, being considered for radical salvage therapy (with curative intent).

• The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with BCR on the basis of:

• Increase in PSA level ~2.0 ng/ml above the nadir level after radiotherapy (RT) or brachytherapy, no previous recurrences of BCR.

• The subject is being considered for radical salvage therapy.

• Should not have received androgen-deprivation therapy within 3 months of screening.

• No hormone therapy within the past three months.

Exclusion Criteria:

Group A:

• Prior Tx for Prostate Tumours

• Gleason < 4+3

• Hip prostheses

• eGFR <20

Group B:

• Hormone Therapy in the last 3 months

• Hip prostheses

• eGFR <20

Group C:

• Hormone Therapy in the last 3 months

• Hip prostheses

• eGFR <20