Back to results68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer (PRONOUNCED)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Gallium-68 THP-PSMA
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
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:
- 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:
- 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
Sites / Locations
- St Bartholomew's Hospital (PIC)
- Royal Free Hospital (PIC)
- Guy's and St Thomas' Hospital (PIC)
- University College Hospital London
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gallium-68 THP-PSMA
Arm Description
Single intravenous administration of Gallium-68 THP-PSMA
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Safety - Treatment Emergent Adverse Events
Safety was assessed by means of physical examination, vital signs, cardiovascular profile, performance status, laboratory evaluations (haematology, biochemistry, urinalysis and prostate-specific antigen), recording of concurrent illness/therapy and AEs. No dose limiting toxicity was defined in this study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03617588
Brief Title
68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer
Acronym
PRONOUNCED
Official Title
A Phase II, Open-label Study to Assess Safety and Clinical Utility of 68Ga-THP-PSMA PET/CT in Patients With High Risk Primary Prostate Cancer or Biochemical Recurrence After Radical Treatment (PRONOUNCED Study)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
June 12, 2019 (Actual)
Study Completion Date
June 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theragnostics Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gallium-68 THP-PSMA
Arm Type
Experimental
Arm Description
Single intravenous administration of Gallium-68 THP-PSMA
Intervention Type
Drug
Intervention Name(s)
Gallium-68 THP-PSMA
Other Intervention Name(s)
THG-001
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.
Primary Outcome Measure Information:
Title
Change in Patient Management
Description
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.
Time Frame
up to 3 months post PET/CT
Secondary Outcome Measure Information:
Title
Safety - Treatment Emergent Adverse Events
Description
Safety was assessed by means of physical examination, vital signs, cardiovascular profile, performance status, laboratory evaluations (haematology, biochemistry, urinalysis and prostate-specific antigen), recording of concurrent illness/therapy and AEs. No dose limiting toxicity was defined in this study.
Time Frame
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.
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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:
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
Facility Information:
Facility Name
St Bartholomew's Hospital (PIC)
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Free Hospital (PIC)
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Guy's and St Thomas' Hospital (PIC)
City
London
Country
United Kingdom
Facility Name
University College Hospital London
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer
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