Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
04/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/03/2016: No publications found, verifying study status with principal investigator.