Prostate Cancer
Conditions
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.
Interventions
DRUGGallium-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.
Sponsors
Theragnostics Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Management | up to 3 months post PET/CT | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Recruitment Period June 18th 2018 to June 12th 2019.
Participants by arm
| Arm | Count |
|---|---|
| Group A Patients with newly diagnosed primary high-risk PCa who were scheduled for RP surgery. | 20 |
| Groups B and C 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). | 29 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Group A | Groups B and C | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 15 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 14 Participants | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 21 Participants | 34 Participants |
| Region of Enrollment United Kingdom | 20 participants | 29 participants | 49 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 20 Participants | 29 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 29 | 0 / 49 |
| other Total, other adverse events | 2 / 20 | 3 / 29 | 5 / 49 |
| serious Total, serious adverse events | 0 / 20 | 0 / 29 | 0 / 49 |
Outcome results
Primary
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.
Time frame: up to 3 months post PET/CT
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Change in Patient Management | change in management plan | 6 Participants |
| Group A | Change in Patient Management | no change in management plan | 14 Participants |
| Groups B and C | Change in Patient Management | change in management plan | 15 Participants |
| Groups B and C | Change in Patient Management | no change in management plan | 14 Participants |
| Full Analysis Set | Change in Patient Management | change in management plan | 21 Participants |
| Full Analysis Set | Change in Patient Management | no change in management plan | 28 Participants |
| Per Protocol Set | Change in Patient Management | no change in management plan | 28 Participants |
| Per Protocol Set | Change in Patient Management | change in management plan | 21 Participants |
Secondary
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.
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Safety - Treatment Emergent Adverse Events | Any serious TEAE | 0 number of subjects |
| Group A | Safety - Treatment Emergent Adverse Events | Any TEAE CTCAE Grade 3 or higher | 1 number of subjects |
| Group A | Safety - Treatment Emergent Adverse Events | Any serious TEAE related to 68Ga-THP-PSMA | 0 number of subjects |
| Group A | Safety - Treatment Emergent Adverse Events | Any TEAE leading to discontinuation from study | 0 number of subjects |
| Group A | Safety - Treatment Emergent Adverse Events | Any TEAE | 2 number of subjects |
| Group A | Safety - Treatment Emergent Adverse Events | Any related TEAE leading to discontinuation | 0 number of subjects |
| Group A | Safety - Treatment Emergent Adverse Events | Any related TEAE CTCAE Grade 3 or higher | 0 number of subjects |
| Group A | Safety - Treatment Emergent Adverse Events | Any TEAE related to 68Ga-THP-PSMA | 1 number of subjects |
| Group A | Safety - Treatment Emergent Adverse Events | Any TEAE with outcome of death | 0 number of subjects |
| Group A | Safety - Treatment Emergent Adverse Events | Any related TEAE with outcome of death | 0 number of subjects |
| Groups B and C | Safety - Treatment Emergent Adverse Events | Any serious TEAE | 0 number of subjects |
| Groups B and C | Safety - Treatment Emergent Adverse Events | Any related TEAE CTCAE Grade 3 or higher | 0 number of subjects |
| Groups B and C | Safety - Treatment Emergent Adverse Events | Any related TEAE with outcome of death | 0 number of subjects |
| Groups B and C | Safety - Treatment Emergent Adverse Events | Any serious TEAE related to 68Ga-THP-PSMA | 0 number of subjects |
| Groups B and C | Safety - Treatment Emergent Adverse Events | Any TEAE CTCAE Grade 3 or higher | 1 number of subjects |
| Groups B and C | Safety - Treatment Emergent Adverse Events | Any TEAE | 3 number of subjects |
| Groups B and C | Safety - Treatment Emergent Adverse Events | Any TEAE leading to discontinuation from study | 0 number of subjects |
| Groups B and C | Safety - Treatment Emergent Adverse Events | Any TEAE with outcome of death | 0 number of subjects |
| Groups B and C | Safety - Treatment Emergent Adverse Events | Any related TEAE leading to discontinuation | 0 number of subjects |
| Groups B and C | Safety - Treatment Emergent Adverse Events | Any TEAE related to 68Ga-THP-PSMA | 1 number of subjects |
| Full Analysis Set | Safety - Treatment Emergent Adverse Events | Any related TEAE leading to discontinuation | 0 number of subjects |
| Full Analysis Set | Safety - Treatment Emergent Adverse Events | Any TEAE | 5 number of subjects |
| Full Analysis Set | Safety - Treatment Emergent Adverse Events | Any TEAE related to 68Ga-THP-PSMA | 2 number of subjects |
| Full Analysis Set | Safety - Treatment Emergent Adverse Events | Any TEAE CTCAE Grade 3 or higher | 2 number of subjects |
| Full Analysis Set | Safety - Treatment Emergent Adverse Events | Any related TEAE CTCAE Grade 3 or higher | 0 number of subjects |
| Full Analysis Set | Safety - Treatment Emergent Adverse Events | Any TEAE with outcome of death | 0 number of subjects |
| Full Analysis Set | Safety - Treatment Emergent Adverse Events | Any related TEAE with outcome of death | 0 number of subjects |
| Full Analysis Set | Safety - Treatment Emergent Adverse Events | Any serious TEAE | 0 number of subjects |
| Full Analysis Set | Safety - Treatment Emergent Adverse Events | Any serious TEAE related to 68Ga-THP-PSMA | 0 number of subjects |
| Full Analysis Set | Safety - Treatment Emergent Adverse Events | Any TEAE leading to discontinuation from study | 0 number of subjects |