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

NCT ID: NCT03617588

Last Updated: 2020-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-18
• Study Completion Date: 2019-06-12

Brief 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Gallium-68 THP-PSMA

Single intravenous administration of Gallium-68 THP-PSMA

Group Type: EXPERIMENTAL

Gallium-68 THP-PSMA

Intervention Type: DRUG

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.

Interventions

Gallium-68 THP-PSMA

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.

Intervention Type: DRUG

Other Intervention Names

THG-001

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Theragnostics Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St Bartholomew's Hospital (PIC)

London, , United Kingdom

Royal Free Hospital (PIC)

London, , United Kingdom

Guy's and St Thomas' Hospital (PIC)

London, , United Kingdom

University College Hospital London

London, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

THERAG0001

Identifier Type: -

Identifier Source: org_study_id