A prospective randomised phase III study of observation versus screening MR... | Not Recruiting
A prospective randomised phase III ... | Not Recruiting
A prospective randomised phase III study of observation versus screening MRI and preemptive treatment in castrate resistant prostate cancer patients with spinal metastasis
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Medical Conditions
  • Prostate Cancer
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN74112318
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-mri-scans-pick-up-early-signs-prostate-cancer-pressing-spine-prompts
Research Details
  • 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
Phase
Phase III
Study Design
Randomised; Interventional; Design type: Screening
Study Type
Interventional
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
Primary Outcome Measures
    Not provided at time of registration
Secondary Outcome Measures
    Not provided at time of registration
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Male
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 541; UK Sample Size: 541
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 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Sutton
SM2 5NG
Trial Contact(s)
Primary Trial Contact
Ms Shama Hassan
-
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Cancer Research UK (UK) Grant Codes: C8262/A13749
Other Study ID Numbers
13129
Sponsor(s)
Institute of Cancer Research Experimental Cancer Medicine Centre
Key Dates

Recruitment Start Date

30 Dec 2012

Recruitment End Date

01 May 2015

Trial Start Date

30 Dec 2012

Trial End Date

01 May 2015

Date added to source

29 Nov 2012

Date updated in source

10 Feb 2016