Condition category
Cancer
Date applied
06/09/2017
Date assigned
13/11/2017
Last edited
14/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Mrs Kathleen Riddle

ORCID ID

Contact details

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

Type

Scientific

Additional contact

Prof Hing Leung

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov 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

Acronym

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

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

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

Condition

Prostate Cancer

Intervention

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

Other

Phase

Drug names

Primary outcome measures

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

01/01/2017

Overall trial end date

01/04/2019

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Male

Target number of participants

60

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

01/01/2018

Recruitment end date

01/07/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Trial participating centre

Addenbrooke's Hospital
Hill's Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Christie Hospital
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom

Trial participating centre

University College London Hospital
235 Euston Road Bloomsbury
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

Common Services Agency

Sponsor details

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

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

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

01/04/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/05/2018: Internal review. 16/01/2018: Internal review.