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

NCT03617588 | Completed Phase 2 Results

• 1 other identifier: THERAG0001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Change in Patient Management

  The impact of 68Ga-THP-PSMA PET/CT on the management of patients with PCa was analysed by measuring the percentage of patients who had a change in management plan as a result of 68Ga-THP-PSMA PET/CT documented after scan, compared with their pre-scan management plan. A change status of 'Yes' was assigned if there was any difference in treatment options between the intended and revised management plans. A change status of 'No' was assigned if the intended and revised management plans remained identical. This endpoint was assessed in the full analysis set, but as a sensitivity analysis, was also assessed in the per protocol population in case there was a difference between the populations. As all 49 patients underwent a technically successful post-baseline scan, the full analysis set and per protocol populations were the same.

  up to 3 months post PET/CT

Secondary Outcomes (1)

• Safety - Treatment Emergent Adverse Events

  Safety was assessed at screening, during the study and at Visit 4. AEs, regardless of relationship to study treatment, were recorded from the time of 68Ga-THP-PSMA administration until 30 days after the administration of 68Ga-THP-PSMA.

Study Arms (1)

Gallium-68 THP-PSMA

EXPERIMENTAL

Single intravenous administration of Gallium-68 THP-PSMA

Drug: Gallium-68 THP-PSMA

Interventions

Gallium-68 THP-PSMA 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.

Also known as: THG-001

Gallium-68 THP-PSMA

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).
• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Theragnostics Ltd: lead

Study Sites (4)

St Bartholomew's Hospital (PIC)

London, EC1A 7BE, United Kingdom

Location

Royal Free Hospital (PIC)

London, NW3 2QG, United Kingdom

Location

Guy's and St Thomas' Hospital (PIC)

London, United Kingdom

Location

University College Hospital London

London, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Theragnostics Ltd

archie.hale@theragnostics.com

+44 330 606 7437

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: August 6, 2018
• Study Start: June 18, 2018
• Primary Completion: June 12, 2019
• Study Completion: June 12, 2019
• Last Updated: June 24, 2020
• Results First Posted: June 24, 2020

Record last verified: 2020-06

Locations

GB (4)