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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2017-005010-59
    Trial protocol
    		 GB  
    Global end of trial date
    12 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jan 2020
    First version publication date
    31 Jan 2020
    Other versions
    Summary report(s)
    		 THERAG0001 CSR Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    THERAG0001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03617588
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Theragnostics Ltd
    Sponsor organisation address
    2 Arlington Square, Bracknell, United Kingdom, RG12 1WA
    Public contact
    Michael Ferris, Clinical Trials Coordinator, Theragnostics Ltd, +44 3306067437, michael.ferris@theragnostics.com
    Scientific contact
    Dr Daniel Stevens, Chief Medical Officer, Theragnostics Ltd, daniel.stevens@theragnostics.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was: - To evaluate 68Ga-PSMA PET/CT impact on the management of patients with prostate cancer (PCa) in the setting of: i) Biochemical recurrence (BCR) in patients treated with prior radical prostatectomy (RP); ii) BCR in patients treated with prior radiotherapy; iii) Newly diagnosed high-risk PCa. The secondary objective of the trial was: - To evaluate the safety of 68Ga-PSMA in patients with PCa.
    Protection of trial subjects
    As per attached synopsis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    22
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a single-centre study conducted at one site in the United Kingdom.

    Pre-assignment
    Screening details
    		 This was an open-label study to assess the safety and clinical utility of 68Ga-THP-PSMA PET/CT in patients with high-risk primary PCa or BCR after radical treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open-label study. No blinding was necessary.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A
    Arm description
    		 Patients with newly diagnosed primary high-risk PCa who were scheduled for RP surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-THP-PSMA
    Investigational medicinal product code
    Other name
    Galliprost
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    68Ga-THP-PSMA was provided as a sterile solution for injection. Prior to PET/CT, 160±30 megabecquerels (MBq) 68Ga-THP PSMA was administered in a single intravenous bolus. The administration was by a slow push over a period of 1 minute, followed by a 10 mL saline flush. 68Ga-THP PSMA was injected via a cannula with the patient lying in a supine position and in an antecubital vein (or another vein that could provide access).

    Arm title
    		 Groups B and C
    Arm description
    		 Group B - patients with PCa and a diagnosis of BCR, previously treated with RP and being considered for radical salvage therapy (with curative intent). Group C - patients with PCa and a diagnosis of BCR, previously treated with radical radiotherapy and being considered for radical salvage therapy (with curative intent).
    Arm type
    		 Experimental

    Investigational medicinal product name
    68Ga-THP-PSMA
    Investigational medicinal product code
    Other name
    Galliprost
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    68Ga-THP-PSMA was provided as a sterile solution for injection. Prior to PET/CT, 160±30 megabecquerels (MBq) 68Ga-THP PSMA was administered in a single intravenous bolus. The administration was by a slow push over a period of 1 minute, followed by a 10 mL saline flush. 68Ga-THP PSMA was injected via a cannula with the patient lying in a supine position and in an antecubital vein (or another vein that could provide access).

    Number of subjects in period 1
    		Group A Groups B and C
    Started
    20
    29
    Completed
    19
    29
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Patients with newly diagnosed primary high-risk PCa who were scheduled for RP surgery.

    Reporting group title
    Groups B and C
    Reporting group description
    		 Group B - patients with PCa and a diagnosis of BCR, previously treated with RP and being considered for radical salvage therapy (with curative intent). Group C - patients with PCa and a diagnosis of BCR, previously treated with radical radiotherapy and being considered for radical salvage therapy (with curative intent).

    Reporting group values
    		 Group A Groups B and C Total
    Number of subjects
    		 20 29 49
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 8 14 22
        From 65-84 years
    		 12 15 27
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 20 29 49
    Subject analysis sets

    Subject analysis set title
    Safety Evaluable Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received a 68Ga-THP-PSMA PET/CT dose, regardless of whether they received the full intended dose, or proceeded to undergo the intended 68Ga-THP-PSMA PET/CT scan.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    A subset of the safety population who underwent the Visit 2 68Ga-THP-PSMA PET/CT scan, regardless of whether the scan was a technical success or failure.

    Subject analysis set title
    Per Protocol Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A subset of the Full Analysis Set with at least one technically successful post baseline 68Ga-THP-PSMA PET/CT scan and without any major protocol deviations.

    Subject analysis sets values
    		 Safety Evaluable Population Full Analysis Set Per Protocol Population
    Number of subjects
    49
    49
    49
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    22
    22
    22
        From 65-84 years
    27
    27
    27
        85 years and over
    0
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    0
    0
    0
        Male
    49
    49
    49

    End points

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    End points reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Patients with newly diagnosed primary high-risk PCa who were scheduled for RP surgery.

    Reporting group title
    Groups B and C
    Reporting group description
    		 Group B - patients with PCa and a diagnosis of BCR, previously treated with RP and being considered for radical salvage therapy (with curative intent). Group C - patients with PCa and a diagnosis of BCR, previously treated with radical radiotherapy and being considered for radical salvage therapy (with curative intent).

    Subject analysis set title
    Safety Evaluable Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received a 68Ga-THP-PSMA PET/CT dose, regardless of whether they received the full intended dose, or proceeded to undergo the intended 68Ga-THP-PSMA PET/CT scan.

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    A subset of the safety population who underwent the Visit 2 68Ga-THP-PSMA PET/CT scan, regardless of whether the scan was a technical success or failure.

    Subject analysis set title
    Per Protocol Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    A subset of the Full Analysis Set with at least one technically successful post baseline 68Ga-THP-PSMA PET/CT scan and without any major protocol deviations.

    Primary: Change in management plan

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    End point title
    		 Change in management plan [1]
    End point 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.
    End point type
    Primary
    End point timeframe
    Details of intended pre-scan patient management plans were collected at Visit 1 (within four weeks of the scan) and compared with post 68Ga-THP-PSMA PET/CT scan management plans collected at Visit 4 (approximately 2 weeks post-scan).
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The primary endpoint, 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 pre-scan management plan, was analysed descriptively.
    End point values
    		 Group A Groups B and C Full Analysis Set Per Protocol Population
    Number of subjects analysed
    20
    29
    49
    49
    Units: Number of patients
        Change in management plan
    6
    15
    21
    21
        No change in management plan
    14
    14
    28
    28
    No statistical analyses for this end point

    Secondary: Safety

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    End point title
    		 Safety
    End point 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.
    End point type
    Secondary
    End point timeframe
    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.
    End point values
    		 Group A Groups B and C Safety Evaluable Population
    Number of subjects analysed
    20
    29
    49
    Units: Number of patients with events
        Any TEAE
    2
    3
    5
        Any TEAE related to 68Ga-THP-PSMA
    1
    1
    2
        Any TEAE CTCAE Grade 3 or higher
    1
    1
    2
        Any related TEAE CTCAE Grade 3 or higher
    0
    0
    0
        Any TEAE with outcome of death
    0
    0
    0
        Any related TEAE with outcome of death
    0
    0
    0
        Any serious TEAE
    0
    0
    0
        Any serious TEAE related to 68Ga-THP-PSMA
    0
    0
    0
        Any TEAE leading to discontinuation from study
    0
    0
    0
        Any related TEAE leading to discontinuation
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting 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.
    Adverse event reporting additional 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.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Group A
    Reporting group description
    		 Patients with newly diagnosed primary high-risk PCa who were scheduled for RP surgery.

    Reporting group title
    Groups B and C
    Reporting group description
    		 Group B - patients with PCa and a diagnosis of BCR, previously treated with RP and being considered for radical salvage therapy (with curative intent). Group C - patients with PCa and a diagnosis of BCR, previously treated with radical radiotherapy and being considered for radical salvage therapy (with curative intent).

    Reporting group title
    Safety Evaluable Population
    Reporting group description
    		 All patients who received a 68Ga-THP-PSMA PET/CT dose, regardless of whether they received the full intended dose, or proceeded to undergo the intended 68Ga THP PSMA PET/CT scan.

    Serious adverse events
    		 Group A Groups B and C Safety Evaluable Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 29 (0.00%)
    0 / 49 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group A Groups B and C Safety Evaluable Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 20 (10.00%)
    3 / 29 (10.34%)
    5 / 49 (10.20%)
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 29 (3.45%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 29 (3.45%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    1
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 29 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    2
    0
    2
    Dizziness
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 29 (3.45%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    1
    Sensory loss
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 29 (3.45%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Catheter site rash
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 29 (3.45%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 29 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 29 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 29 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 29 (3.45%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Oct 2018
    This amendment resulted in protocol version 2.0, dated 29 October 2018. The following changes were made: Inclusion and exclusion criteria were updated to provide greater detail and clarity for each criterion. Schedule of events was updated to remove Visit 5. A single interim analysis was introduced to provide some early indication of the study results and to consider the primary study outcome, patient background and management. Additional administrative corrections (spelling mistakes and formatting) were made.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    20 May 2019
    The decision was made to terminate the study early on 20 May 2019 as there was considered to be sufficient safety and efficacy data available to perform the outcome analysis. There were no consequences to the overall risk benefit assessment of the IMP as the decision to stop the trial was not based on safety grounds or toxicity. Three patients were still on study at the time of early termination and continued on study until their last visit.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    As per the protocol, 20 patients were planned to be enrolled into Group C. However, only 8 patients were enrolled. This was due to a very high change in management rates and difficulty recruiting at site due to their clinical practice preferences.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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