Condition category
Cancer
Date applied
16/02/2016
Date assigned
17/02/2016
Last edited
02/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Mrs Laura Alexander

ORCID ID

Contact details

CRUK Clinical Trials Unit
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
0141 301 7212
laura.alexander@glasgow.ac.uk

Additional identifiers

EudraCT number

2015-003720-32

ClinicalTrials.gov number

Protocol/serial number

SPECTRE2015

Study information

Scientific title

SPECTRE - Combined suppression of cholesterol bioavailability and androgen deprivation therapy to treat castration resistant prostate cancer: an interventional study

Acronym

SPECTRE

Study hypothesis

SPECTRE will establish whether inhibition of cholesterol biosynthesis in patients with ongoing ADT will suppress castration-resistant prostate cancer via a reduction in androgen mediated signalling.

Ethics approval

Not provided at time of registration

Study design

Single centre single arm phase II interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Castration resistant prostate cancer

Intervention

All eligible patients will receive a statin (Atorvastatin) to take orally for a 6 week period. Patients will be asked to attend the clinic once a week for 7 weeks, during the course of the trial. After completion of the trial medicine patients will attend for a further clinic visit, four weeks later. During each clinic visit, patients will be checked to ensure they are well, any side effects will be monitored and a blood test will be performed. Patients will also be asked to provide consent for additional blood samples at each study visit. These samples will be analysed in order to develop highly specific tests that will track the status of prostate cancer. Patients may also be requested to provide consent for two biopsy samples of their tumour; one before starting the trial medication, and another 5-7 weeks later. Biopsy samples will not be required from all patients taking part in the study.

Intervention type

Drug

Phase

Phase II

Drug names

Atorvastatin

Primary outcome measures

Achievement of ≥50% drop from baseline in PSA levels at any time over the 6-week period of statins treatment (PSA response). The proportion of patients achieving PSA response rate will be presented together with an 80% confidence interval computed using the Clopper-Pearson approach.

Secondary outcome measures

1. Maximum percentage drop in PSA, determined for each patient and presented in a waterfall plot.
2. Change in levels of a number of biomarkers (circulating and tissue) following treatment with trial agent, including circulating cell-free tumour DNA (ctDNA), gene expression and other markers such as CTCs and exosomes

Overall trial start date

01/07/2016

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically proven adenocarcinoma of the prostate (patients may or may not have evidence of metastatic disease)
2. Disease progression despite on-going castration therapy (either using LHRH analogue or prior surgical orchiectomy) as judged by rising serial PSA measurements: This will be based on a series of at least 3 readings each taken at least 7 days apart. The 3rd reading must be ≥2 ng/ml. In the event where an intermediate reading is lower than a previous reading, then the patient will still be eligible (i.e. the 3 readings do not need to be consecutive). In patients who have received prior bicalutamide, flutamide or nilutamide, PSA progression must be proven after withdrawal of this drug
3. Castrate levels of serum testosterone (<1.7 nmol/l)
4. Ongoing castration therapy (either LHRH analogue or prior orchiectomy)
5. No therapy with statins or other cholesterol-lowering drug during a 2-month period prior to initiation of trial medication
6. Male aged 18 or over
7. Life expectancy greater than 6 months
8. Adequate hepatic, bone marrow coagulation and renal function as defined by the following criteria:
8.1. Haemoglobin > 9.0 g/dL
8.2. Platelets > 100 x 109L
8.3. Creatinine <2 x ULN
8.4. Hepatic function: total bilirubin ≤ 2 x ULN; ALT and AST ≤ 3 x ULN
8.5. Creatine kinase ,≤ 5 x ULN
8.6. Fasting glucose ≤ 5.6 mmol/L
8.7. Prothrombin time ≤ 1.5 x ULN; APTT ≤ 1.5 x ULN
8.8. Platelets ≥ 100
9. Willingness to comply with scheduled visits, treatment plans and laboratory tests and other trial procedures
10. Ability to swallow oral medications
11. Willing to undergo two biopsies

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

40

Participant exclusion criteria

1. Uncontrolled hypertension (defined as systolic ≥ 170mmHg and/or diastolic ≥ 100 mmHg despite optimal therapy)
2. The requirement for strong opiates to control cancer related pain; codeine and tramadol are
permitted
3. NYHA class III or IV heart failure or Childs-Pugh liver failure class B or worse
4. Patients with symptomatic or radiographic disease progression (Note: Imaging studies will not be conducted specifically to meet this criterion but only if clinically indicated in accordance with standard of care)
5. Other severe or uncontrolled systemic disease or evidence of any other significant disorder or lab finding that makes it undesirable for the patient to participate in the trial
6. History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol, or any psychological, familial, sociological or geographical consideration potentially hampering compliance with the trial protocol and follow up schedule. Administration of any investigational drug within 28 days of receiving the first dose of trial treatment
7. Major surgery within 28 days prior to trial entry
8. Active condition which affects drug absorption (e.g. prior gastrectomy or active peptic ulcer disease)
9. Planned change in systemic therapy for 6 weeks after study initiation
10. Planned requirement for radiotherapy or surgery for 6 weeks after study initiation
11. Prior hypersensitivity to atorvastatin or its constituents
12. Requirement for on-going anti-coagulant therapy (including heparins and warfarin)

Recruitment start date

01/07/2016

Recruitment end date

30/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow & Clyde

Sponsor details

Research & Development
NHS Greater Glasgow & Clyde
West Glasgow Ambulatory Care Hospital
Dalnair Street
Glasgow
G3 8SW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Organisation

University of Glasgow

Sponsor details

Clinical Research & Development
West Glasgow Ambulatory Care Hospital
Dalnair Street
Glasgow
G3 8SW
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Prostate Cancer UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Intention to publish date

31/08/2018

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

02/09/2016: Cancer Help UK lay summary link added.