Condition category
Cancer
Date applied
28/11/2012
Date assigned
29/11/2012
Last edited
10/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Shama Hassan

ORCID ID

Contact details

15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
-
prompts-icrctsu@icr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13129

Study information

Scientific title

A prospective randomised phase III study of observation versus screening MRI and preemptive treatment in castrate resistant prostate cancer patients with spinal metastasis

Acronym

PROMPTS

Study hypothesis

Does detection of radiological spinal cord compression (rSCC) by screening magnetic resonance imaging (MRI) of the spine and pre-emptive treatment reduce the incidence of clinical spinal cord compression (SCC) in asymptomatic castrate resistant prostate cancer (CRPC) patients with spinal metastasis?

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13129

Ethics approval

12/LO/1109

Study design

Randomised; Interventional; Design type: Screening

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Prostate Cancer

Intervention

Control Group: Patients followed up as per standard practice i.e. in accordance with National Institute of Clinical Excellence (NICE) guidelines, MRI spine performed if patient develops clinical neurological deficit or significant spinal pain with treatment given if there is overt SCC on MRI.

Intervention Group, Baseline screening MRI and pre-emptive treatment to sites of radiological (r) SCC; following pre-emptive treatment patients will receive an MRI scan every 6 months (rSCC is defined as radiological spinal cord compromise).

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/12/2012

Overall trial end date

01/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically / cytologically confirmed adenocarcinoma of the prostate or clinical diagnosis of prostate cancer with osteoblastic bone metastases and Prostate-specific antigen (PSA) ≥ 100ng/ml
2. Castrate resistant disease*
3. One or more spinal metastasis on imaging (technetium bone scan with confirmatory X-ay as appropriate clinically) undertaken at any time during the patient’s illness
4. Life expectancy of 6 months or more
5. Eastern Cooperative Oncology Group (ECOG) performance status 02
6. Written, informed consent
*(rising PSA (> 5 ng /ml and >50% rise from nadir) after luteinizing hormone releasing hormone agonist (LHRHa) therapy or orchidectomy with or without antiandrogen)

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 541; UK Sample Size: 541

Participant exclusion criteria

1. Back pain related to metastatic cancer, requiring regular (daily) analgesics
2. Previous active malignancy within the last 5 years other than basal cell carcinoma or low grade superficial bladder cancer
3. Current or previous spinal cord compression (SCC) or neurologic deficit
4. Brain metastasis
5. Spinal MRI within last 12 months
6. CT or PET CT scan of thorax AND abdomen within the last 6 months
7. Previous external beam radiotherapy to the vertebra or spinal surgery with the primary aim to prevent or treat SCC+
8. Serious or uncontrolled coexistent non-malignant diseases
9. Any contra indications for MRI
10. Inability to comply with neurologic and Quality of Life (QoL) assessments
11. Previous palliative radiotherapy to painful spinal metastases in now asymptomatic patients is permissible

Recruitment start date

30/12/2012

Recruitment end date

01/05/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

15 Cotswold Road
Sutton
SM2 5NG
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research Experimental Cancer Medicine Centre

Sponsor details

Cancer Research
123 Old Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Research organisation

Website

http://www.ecmcnetwork.org.uk/network-centres/london-institute-cancer-research/

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK) Grant Codes: C8262/A13749

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

10/02/2016: No publications found, verifying study status with principal investigator