68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: Gallium-68 THP-PSMA
Intervention description: Subjects will undergo a Gallium-68 THP-PSMA scan in addition to standard of care monitoring. The results of this scan may influence the patient management plan.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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