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 |
| EudraCT/CTIS number | 2005-006018-16 |
| Secondary identifying numbers | N0258175363 |
- 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
Scientific
Academic Urology Unit
Royal Marsden NHS Trust
Orchard House
Downs Road, Sutton
Surrey
SM2 5PT
United Kingdom
| Phone | +44 020 8661 3425 |
|---|---|
| chris.parker@rmh.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2006 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Academic Urology Unit
Surrey
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
The Royal Marsden NHS Foundation Trust (UK)
No information available
NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
02/05/2018: Publication reference added.
04/03/2016: No publications found, verifying study status with principal investigator.
