Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information



Primary contact

Mrs Kathleen Riddle


Contact details

Scottish Clinical Trials Research Unit
Information Services Division
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
EH12 9EB
United Kingdom



Additional contact

Prof Hing Leung


Contact details

CRUK Beatson Institute and University of Glasgow
Garscube Estate
Switchback Road
G61 1BD
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

PSMA Imaging 1.0

Study information

Scientific title

Evaluation of PSMA (68Ga) PET/CT as a tool to guide treatment choice in patients with high risk prostate cancer


PSMA Imaging

Study hypothesis

The aim of this study is to evaluate if the PSMA PET/CT scan will identify whether or not the cancer has spread to the lymph nodes. This will mean that for future patients, whose cancer without evidence of having spread to the lymph nodes, can have less extensive surgery. They will not have to have their pelvic lymph nodes removed at the time of surgery

Ethics approval

'Not provided at time of registration'

Study design

PSMA Imaging is a feasibility study looking at patients who have high risk prostate cancer (in the absence of clinical evidence for distant metastasis) opting for surgical intervention with radical prostatectomy and extended pelvic lymphadenectomy. 60 patients will be recruited over a 6 month period from 4 centres within the United Kingdom.
Patients who have signed informed consent and who have met all eligibility criteria will be enrolled into the trial.
Once enrolled all patients will have a PSMA PET/CT scan prior to (and within 2 weeks of) surgery, in addition to standard of care imaging as per local clinical practice.

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.


Prostate Cancer


Participants attend a screening visit. Informed consent, medical history, a physical examination and a number of blood tests are taken at this visit.

Participants receive only one extra scan (out with any other standard care scans required) which is called a (Ga68) PSMA PET/CT scan. Participants then have their elective surgery as schedules.

Participants attend a six week follow up visit. A physical examination and the same blood tests will be done again six weeks after their surgery. The surgeon will also discuss the outcome of the surgery that they have had and will discuss any future management of care.

Intervention type



Drug names

Primary outcome measure

1.SUVmax is measured for each lesion using the 68Ga-PSMA PET/CT within 2 weeks of a scheduled RP and ePLND this will be used along with independent nuclear medicine physicians to determine the sensitivity, specificity, positive predictive and negative predictive values of 68Ga-THP-PSMA imaging in detecting pelvic nodal metastasis
2. The establishment of best practice will be measured by the production of protocols for multi-centre application of PSMA PET/CT imaging

Secondary outcome measures

1. The use of novel 68Ga-THP-PSMA radiopharmaceutical is measured using the successful assessment of 60 patients through to the end of study and inclusion in the study analysis
2. Feasibility of a future large scale randomised controlled trial is measured using recruitment of 60 patients into the study within the proposed timelines and by the development of quality assurance measures across the study team/network
3. The development of a platform to carry out RCT to study the usefulness of novel imaging/biomarkers for evidence-based treatment decisions in patients at risk of pelvic nodal prostate cancer is measured by the future development of RCT’s in this area.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. High risk prostate cancer with no detectable metastasis using standard of care imaging (MRI prostate/pelvis, isotope bone scan, CT, non-PSMA PET/CT) undergoing radical prostatectomy and pelvic lymph node dissection
2. Histologically proven prostate cancer
3. No prior prostate cancer treatment including androgen deprivation therapy
4. Male aged 18 or over
5. Considered suitable candidate for radical surgery for prostate cancer
6. Adequate hepatic, bone marrow, coagulation and renal function as defined by the following criteria:
6.1. Haemoglobin > 9.0 g/dL
6.2. Platelets > 100 x 109 L
6.3. Creatinine <2 x ULN
6.4. Hepatic function: total bilirubin ≤ 2 x ULN; ALT and AST ≤ 3 x ULN
6.5. Prothrombin time ≤ 1.5 x ULN; APTT ≤ 1.5 x ULN
7. Willingness to comply with scheduled visits (including an additional PET/CT scan)

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Evidence of demonstrable metastasis on standard of care imaging using combination of MRI, CT and isotopic bone scan
2. Patients not willing to receive surgical treatment with radical prostatectomy and pelvic node dissection
3. Patients not able to undergo PET/CT scan because of weight (e.g. >180 kg), claustrophobia, or not able to lie still during the scanning duration
4. Patients who already had PSMA PET/CT scan for diagnosis of prostate cancer
5. Patients who are unable or unwilling to give informed consent

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth University Hospital
1345 Govan Road
G51 4TF
United Kingdom

Trial participating centre

Addenbrooke's Hospital
Hill's Road
United Kingdom

Trial participating centre

Christie Hospital
550 Wilmslow Road
M20 4BX
United Kingdom

Trial participating centre

University College London Hospital
235 Euston Road Bloomsbury
United Kingdom

Sponsor information


Common Services Agency

Sponsor details

Strategic Business Unit
Public Health and Intelligence (Information Services Division)
Gyle Square
1 South Gyle Crescent
EH12 9EB
United Kingdom

Sponsor type




Funder type


Funder name

Cancer Research UK

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal. Intent to publish approximately 01/04/2020.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date


Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/03/2019: Internal review. 06/06/2018: Internal review 14/05/2018: Internal review. 16/01/2018: Internal review.