Clinical trial NCT03617588: 68Ga-THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Theragnostics Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-06
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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:

  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

Primary outcomes:
measure: Change in Patient Management
timeFrame: up to 3 months post PET/CT
Secondary outcomes:
measure: Safety - Treatment Emergent Adverse Events
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.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bartholomew's Hospital (PIC)
city: London
country: United Kingdom
facility: Royal Free Hospital (PIC)
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital (PIC)
city: London
country: United Kingdom
facility: University College Hospital London
Study officials:
References: