ISRCTN - ISRCTN24991896: A randomised clinical trial of hormones plus radiotherapy vs hormone therapy alone in non-metastatic prostate cancer

Plain English Summary

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-hormone-therapy-with-or-without-radiotherapy-in-advanced-prostate-cancer

Trial website

Contact information

Type

Scientific

Primary contact

Prof MK Parmar

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
-
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00002633

Protocol/serial number

G9805643 (PR07)

Study information

Scientific title

A randomised clinical trial of hormones plus radiotherapy vs hormone therapy alone in non-metastatic prostate cancer

Acronym

Study hypothesis

To evaluate any possible benefit from the addition of external beam radiation therapy to the treatment of patients with non-metastatic prostate cancer who have not had a radical prostatectomy and are receiving hormonal therapy.

More details can be found at: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=58

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prostate cancer

Intervention

All patients will receive hormonal manipulation.
Patients are randomised to receive:
1. Additional radiotherapy (65-69Gy/35-37f)
2. No additional radiotherapy

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Overall survival

Secondary outcome measures

1. Time to disease progression
2. Symptomatic local control measured by the rates of surgical interventions necessary for symptomatic local disease (I.e. the combined incidences of TURPs, stent insertions, nephrostomies and colostomies)
3. Quality of Life measured by the FACT-P questionnaire

Overall trial start date

01/06/1999

Overall trial end date

31/08/2005

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Histological diagnosis of adenocarcinoma of the prostate within 6 months of randomisation
2. Either (a) clinical stage T3 or T4, NO or NX, MO or (b) clinical stage T2, NO or NX, MO with Prostate-Specific Antigen (PSA) greater than 40 or (c) clinical stage T2, NO or NX, MO with PSA greater than 20 and Gleason sum score greater than or equal to 8
3. The patient must have a bone scan (with X-rays of any areas of abnormal uptake) reported as being free of evidence of bony metastases within 16 weeks prior to randomisation (if not already on hormones) or 16 weeks prior to the start of hormones (if on hormones already)
4. No previous treatment for prostate cancer apart from transurethral resection. However, the patient may have received prior hormone therapy during the 12 weeks prior to randomisation, provided that (a) a negative bone scan was demonstrated, preferably within the 16 weeks prior to starting hormone therapy but certainly within 2 weeks after starting hormone therapy and (b) baseline PSA within 4 weeks prior to hormone therapy is available
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Patients must be less than 80 years old
7. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

1,200

Participant exclusion criteria

1. A history of previous or concurrent malignancy other than non-melanomatous skin cancer within 5 years of diagnosis of the prostatic cancer.
2. The presence of small-cell or transitional-cell carcinoma in the biopsy specimen.
3. Any contraindication to pelvic radiotherapy (e.g. inflammatory bowel disease).
4. Any serious non-malignant disease resulting in a life expectancy of less than 5 years.

Recruitment start date

01/06/1999

Recruitment end date

31/08/2005

Locations

Countries of recruitment

United Kingdom, United States of America

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) Clinical Trials Unit - Cancer Division (UK)

Sponsor details

222 Euston Road
London
NW1 2DA
United Kingdom
-
abc@email.com

Sponsor type

Research council

Website

http://www.ctu.mrc.ac.uk/

Funders

Funder type