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

Theragnostics

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Gallium-68 THP-PSMA

Study type: Interventional

Funder types: Industry

Identifiers

NCT03617588

THERAG0001

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Gallium-68 THP-PSMA

Experimental group

Description:

Single intravenous administration of Gallium-68 THP-PSMA

Treatment:

Drug: Gallium-68 THP-PSMA