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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03617588
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Theragnostics Ltd

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Gallium-68 THP-PSMA Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : June 18, 2018
Actual Primary Completion Date : June 12, 2019
Actual Study Completion Date : June 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Gallium

Arm Intervention/treatment
Experimental: Gallium-68 THP-PSMA
Single intravenous administration of Gallium-68 THP-PSMA
Drug: 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.
Other Name: THG-001




Primary Outcome Measures :
  1. Change in patient management [ Time Frame: up to 3 months post PET/CT ]
    Change in patient management as a result of 68Ga-PSMA PET documented after scan, compared with pre-scan management plan.


Secondary Outcome Measures :
  1. Treatment Emergent Adverse Events [Safety and tolerability] [ Time Frame: up to 3 month post PET/CT ]

Other Outcome Measures:
  1. Histopathology [ Time Frame: up to 3 month post PET/CT ]
    Positive histopathological staining for PSMA as per standard of care where histology is available



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617588


Locations
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United Kingdom
St Bartholomew's Hospital (PIC)
London, United Kingdom, EC1A 7BE
Royal Free Hospital (PIC)
London, United Kingdom, NW3 2QG
Guy's and St Thomas' Hospital (PIC)
London, United Kingdom
University College Hospital London
London, United Kingdom
Sponsors and Collaborators
Theragnostics Ltd
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Responsible Party: Theragnostics Ltd
ClinicalTrials.gov Identifier: NCT03617588    
Other Study ID Numbers: THERAG0001
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes