- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03617588
68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer (PRONOUNCED)
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 Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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London, United Kingdom
- University College Hospital London
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London, United Kingdom, EC1A 7BE
- St Bartholomew's Hospital (PIC)
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London, United Kingdom, NW3 2QG
- Royal Free Hospital (PIC)
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London, United Kingdom
- Guy's and St Thomas' Hospital (PIC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Gallium-68 THP-PSMA
Single intravenous administration of Gallium-68 THP-PSMA
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Management
Time Frame: up to 3 months post PET/CT
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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.
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up to 3 months post PET/CT
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety - Treatment Emergent Adverse Events
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.
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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.
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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.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THERAG0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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