Contact information
Type
Scientific
Primary contact
Dr Christopher Parker
ORCID ID
Contact details
Academic Urology Unit
Royal Marsden NHS Trust
Orchard House
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
+44 020 8661 3425
chris.parker@rmh.nhs.uk
Additional identifiers
EudraCT number
2005-006018-16
ClinicalTrials.gov number
Protocol/serial number
N0258175363
Study information
Scientific title
A randomised phase III trial of low dose daily dexamethasone versus intermittent dexamethasone versus prednisolone in hormone refractory prostate cancer (The PoD Trial)
Acronym
PoD
Study hypothesis
The trial aims to evaluate and compare the efficacy of two regimens of dexamethasone (low dose daily and intermittent) and compare them with the standard hormone treatment (Prednisolone) in Hormone Refractory Prostate Cancer (HRPC).
Ethics approval
Royal Marsden NHS Regional Ethics Committee, 24/07/2008, ref : 06/Q0801/2
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer: Prostate
Intervention
Randomised test intervention vs standardized intervention, non-blinded (Phase III)
Intervention type
Drug
Phase
Phase III
Drug names
dexamethasone versus prednisolone
Primary outcome measure
To evaluate the PSA response rate of daily dexamethasone and of intermittent dexamethasone in patients with hormone refractory prostate cancer.
Secondary outcome measures
Added 24 July 2008:
1. To evaluate the clinical and biochemical parameters which influence PSA response to oral steroids in HRPC
2. To evaluate the duration of PSA response to dexamethasone in HRPC
3. To evaluate the time to PSA progression on dexamethasone in HRPC
4. To evaluate the objective response rate using RECIST criteria of dexamethasone in HRPC
5. To evaluate the effect of dexamethasone on pain control and time to skeletal events in HRPC
6. To evaluate the effect of dexamethasone on alkaline phosphatase and haemoglobin in HRPC
7. To evaluate the effect on levels of steroid hormones and steroid metabolites
8. To evaluate the safety and tolerability of dexamethasone in HRPC
9. To evaluate the effect of dexamethasone on overall survival in HRPC
Overall trial start date
01/02/2006
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with histologically or cytologically confirmed adenocarcinoma of the prostate to sclerotic bone metastases/increased tracer uptake on bone scan in a patient presenting with a PSA>100
2. Serum testosterone <2nmol/l
3. Ongoing androgen deprivation therapy with LHRH analogues or bilateral orchidectomy
4. Progressive disease defined as a PSA rise using 3 serum PSA measurements, each obtained at least 7 days apart within the 3 months prior to start of trial
5. Patient with progression of measurable disease (RECIST) or progression of bone disease must also fit the criterion for PSA progression
6. PSA >5
7. Life expectancy of >3 months
8. Stable/optimum analgesia
9. ECOG performance status 0-3
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
84
Participant exclusion criteria
1. Previous radiotherapy to the head and neck region
2. Previous malignancy except non-melanoma skin cancer
3. Pre-existing hearing loss or significant auditory pathology
4. Previous or concurrent illness, which in the investigators opinion would interfere with either completion of therapy or follow-up
5. Concomitant chemotherapy is not permitted
Recruitment start date
01/02/2006
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Urology Unit
Surrey
SM2 5PT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Royal Marsden NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25457497