NCT02785627

Brief Summary

The ANTELOPE trial is a longitudinal observational clinical study of changes in bone density, structure and strength over 12 months in men receiving treatment for prostate cancer. Three groups (n = 30 per group) will be compared, with bone assessments at baseline and 12 months. Allowing for a 18 month recruitment period, 12 months follow-up and data analysis, the total study length will be 3 years. The groups comprise: Group A - Men with prostate cancer starting ADT Group B - Men with newly diagnosed hormone sensitive metastatic prostate cancer, about to start (or have started within the past 3 months) ADT and who will undergo chemotherapy with docetaxel and prednisolone Group C - Age-matched men without prostate cancer

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 30, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 30, 2016

Status Verified

May 1, 2016

Enrollment Period

2.5 years

First QC Date

May 19, 2016

Last Update Submit

May 24, 2016

Conditions

Prostate Cancer

Keywords

Bone healthBone microarchitectureAndrogen deprivation therapy (ADT)

Outcome Measures

Primary Outcomes (1)

  • Change in volumetric bone mineral density at the distal radius

    Assessed by HR-pQCT in the ADT group (Group A)and compared to the control group (Group C)

    12 months

Secondary Outcomes (3)

  • Characterisation of the microstructural pattern of bone loss in men receiving treatments for prostate cancer.

    12 months

  • Correlation of bone loss and microstructural change with biochemical markers of bone turnover, serum testosterone levels and changes in muscle strength and body composition.

    12 months

  • Characterisation of the microstructural pattern of bone loss at the spine (T12)

    12 months

Study Arms (3)

Group A: ADT

Men with non-metastatic prostate cancer, about to start or within 2 weeks of starting ADT

Other: Comprehensive bone health assessment

Group B: ADT + chemotherapy

Men with newly diagnosed hormone sensitive metastatic prostate cancer, starting ADT and who will have chemotherapy

Other: Comprehensive bone health assessment

Group C: Controls

Healthy age matched men

Other: Comprehensive bone health assessment

Interventions

Comprehensive bone health assessmentOTHER

Blood sample taken for biomarkers of bone turnover, anthropometric measurements, assessments of physical function, DXA scan, HR CT T12 vertebra, Xtreme pQCT radius

Group A: ADTGroup B: ADT + chemotherapyGroup C: Controls

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men aged 50-80 years

You may qualify if:

  • All participants
  • Men aged 50-80 years old, WHO performance status ≤2.
  • Have provided written informed consent prior to any trial-specific procedures
  • Able and willing to comply with the terms of the protocol and to undertake the trial assessments
  • Body Mass Index (kg/m2) \>18.5 and \<35.0
  • No evidence of significantly abnormal organ function on standard laboratory testing
  • Group A
  • Histological confirmation of prostate cancer
  • No indication of metastatic disease
  • Scheduled to commence ADT (but must have baseline assessments carried out within 4 weeks of commencement of ADT). Those starting ADT are expecting to have a duration of treatment of 12 months or more.
  • No prior systemic therapy for advanced prostate cancer (not receiving concurrent anti-neoplastic therapy, besides ADT or an anti-androgens), participants may have received radiotherapy or may receive this during the study period
  • Group B
  • Men with newly diagnosed hormone sensitive metastatic prostate cancer who have commenced ADT and who have been referred for chemotherapy
  • Bone metastases will be allowed provided not in the radius (DXA measurement will attempt to image sites with no/minimal bone metastases)
  • Men who have received palliative radiotherapy for known bone metastases prior to or during the study may be included, but the site of radiotherapy must be accurately recorded and attempts will be made to avoid such sites in subsequent DXA measurement.
  • +4 more criteria

You may not qualify if:

  • Known metabolic bone disease or other diseases (other than prostate cancer) known to affect bone metabolism including: hyperthyroidism, primary hyperparathyroidism, chronic liver disease, rheumatoid arthritis, inflammatory bowel disease or malabsorption
  • Medications (in addition to ADT) known to affect bone metabolism including osteoporosis treatments and anti-epileptics
  • Previous hormone treatments within 1 month (other than ADT in Groups A and B)
  • Any concurrent or recent other invasive cancer that could confuse diagnosis or endpoints. Allowed situations include, but are not limited to, non-melanoma skin cancer, superficial bladder cancer (if in doubt please discuss with trial team).
  • Fracture or orthopaedic surgery within the last 12 months
  • Arthritis, orthopaedic surgery or other abnormality of the radius, spine or hip which would prevent accurate acquisition of study measurements.
  • Current or prior (within one month) participation in any other clinical trial involving a medicinal product, except STAMPEDE for men in group B. For other trial, please consult trial team.
  • For Group B, those on bisphosphonates or alpha-radon on study entry are excluded (but please see separate advice on Pg 19 for men who need to go on bisphosphonates or alpha-radon whilst on study).
  • Groups A and C: Men taking oral systemic corticosteroids (inhaled steroids will be permitted). In Group B oral corticosteroids are permitted, provided that the dose does not exceed 2mg dexamethasone or 10mg prednisolone daily. Those in group B may also receive additional steroids given as prophylaxis alongside chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Clinical Trials Centre

Sheffield, South Yorkshire, S10 2SJ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Janet E Brown, MBBS MD FRCP

CONTACT

0114-226-5202j.e.brown@sheffield.ac.uk

Catherine Handforth, MBChB

CONTACT

0114-226-5202c.handforth@sheffield.ac.uk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Translational Medical Oncology

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 30, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2019

Study Completion

September 1, 2019

Last Updated

May 30, 2016

Record last verified: 2016-05

Locations

GB(1)