A randomised phase III trial of low dose daily dexamethasone versus intermittent dexamethasone versus prednisolone in hormone refractory prostate cancer (The PoD Trial)

ISRCTN	ISRCTN54716369
DOI	https://doi.org/10.1186/ISRCTN54716369
Clinical Trials Information System (CTIS)	2005-006018-16
Protocol serial number	N0258175363
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	The Royal Marsden NHS Foundation Trust (UK), NHS R&D Support Funding

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 02/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Christopher Parker
Scientific

Academic Urology Unit
Royal Marsden NHS Trust
Orchard House
Downs Road, Sutton
Surrey
SM2 5PT
United Kingdom

Phone	+44 020 8661 3425
Email	chris.parker@rmh.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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)
Study acronym	PoD
Study objectives	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(s)	Royal Marsden NHS Regional Ethics Committee, 24/07/2008, ref : 06/Q0801/2
Health condition(s) or problem(s) studied	Cancer: Prostate
Intervention	Randomised test intervention vs standardized intervention, non-blinded (Phase III)
Intervention type	Drug
Phase	Phase III
Drug / device / biological / vaccine name(s)	dexamethasone versus prednisolone
Primary outcome measure(s)	To evaluate the PSA response rate of daily dexamethasone and of intermittent dexamethasone in patients with hormone refractory prostate cancer.
Key secondary outcome measure(s)	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
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	84
Key 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
Key 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
Date of first enrolment	01/02/2006
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Academic Urology Unit

Surrey
SM2 5PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

02/05/2018: Publication reference added.
04/03/2016: No publications found, verifying study status with principal investigator.