Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who... | Not Recruiting
Radiation Therapy and Androgen Depr... | Not Recruiting
Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (RADICALS)

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Medical Conditions
  • Gastrointestinal Complications
  • Prostate Cancer
  • Sexual Dysfunction
  • Urinary Complications
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT00541047
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy, such as goserelin, leuprolide, or bicalutamide, may lessen the amount of androgens made by the body. Giving radiation therapy together with androgen deprivation therapy may kill more prostate cancer cells.

PURPOSE: This randomized phase III trial is studying how well giving radiation therapy together with androgen deprivation therapy works in treating patients who have undergone surgery for prostate cancer.
Research Details
  • OBJECTIVES:

    - Assess the timing of radiotherapy and the use of hormone therapy in conjunction with post-operative radiotherapy.

    - Determine the impact of radiotherapy on general quality of life, sexual function, urinary function, and bowel function.

    - Determine the impact of duration of hormone therapy on general quality of life and sexual function.

    OUTLINE: This is a multicenter study. Patients requiring immediate radiotherapy (RT) are assigned to arm I; patients do not require immediate RT are assigned to arm II. Patients for whom the need of immediate post-operative radiotherapy are uncertain undergo radiotherapy timing randomization within 3 months after surgery and are randomized to 1 of 2 radiotherapy arms.

    - Arm I (immediate RT): Within 2 months after randomization, patients undergo radiotherapy to the prostate bed once a day, 5 days a week, for 4 (20 fractions total) or 6.5 weeks (33 fractions total). They may also undergo radiotherapy to the pelvic lymph nodes once a day, 5 days a week, for 4.5 weeks (23 fractions total) at the investigator's discretion.

    - Arm II (early salvage RT in case of PSA failure): Within 2 months of confirmation of post-operative biochemical failure, patients undergo radiotherapy as in arm I.

    Patients undergoing immediate RT and patients who eventually need early salvage RT undergo hormone therapy duration randomization before the administration of post-operative radiotherapy. Patients are randomized to 1 of 3 hormone therapy arms.

    - Arm III (no hormone therapy): Patients do not receive hormone therapy. They receive post-operative RT alone as described above in arm I or II.

    - Arm IV (RT and short-term hormone therapy): Beginning approximately 2 months prior to the start of RT, patients receive hormone therapy for 6 months. Hormone therapy* may comprise of LHRH agonist (gonadotrophin-releasing hormone analogue [GnRHa] [e.g., goserelin or leuprolide acetate]) or bicalutamide daily.

    - Arm V (RT and long-term hormone therapy): Beginning approximately 2 months prior to the start of RT, patients receive hormone therapy for 24 months. Hormone therapy* may comprise of LHRH agonist (gonadotrophin-releasing hormone analogue [GnRHa] [e.g., goserelin or leuprolide acetate]) or bicalutamide daily.

    NOTE: *For Canadian patients, hormonal therapy will consist of LHRH analog (leuprolide acetate) therapy only.

    Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed using self-administered questionnaires at baseline and 1, 5, and 10 years after randomization. Health economics information is also collected via patient-administered questionnaires (EQ-5D) at baseline and at 1, 5 and 10 years after randomization.

    After completion of study treatment, patients are followed for 7 years.
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : bicalutamide, Drug : goserelin acetate, Drug : leuprolide acetate, Procedure : adjuvant therapy, Procedure : quality-of-life assessment, Radiation : radiation therapy

Study Arm Groups : , , , , ,

Intervention Type
See Interventions above
Primary Outcome Measures
    Disease-specific survival (i.e., death due to prostate cancer); null
Secondary Outcome Measures
    Freedom from treatment failure; null; Clinical progression-free survival; null; Overall survival; null; Non-protocol hormone therapy; null; Treatment toxicity; null; Patient reported outcomes; null
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Male
Age Range
N/A - N/A
Who Can Participate
Patients
Number of Participants
4000
Participant Inclusion Criteria
    DISEASE CHARACTERISTICS:

    Inclusion criteria:

    - Diagnosis of nonmetastatic adenocarcinoma of the prostate

    - Must have undergone radical prostatectomy

    - Post-operative serum prostate-specific antigen (PSA) < 0.4 ng/mL

    - No post-operative biochemical failure, defined as EITHER two consecutive rises in PSA and final PSA > 0.1 ng/mL OR three consecutive rises in PSA (for patients undergoing hormone therapy duration randomization)

    Exclusion criteria:

    - Known distant metastases from prostate cancer

    - PSA > 5 ng/mL at the time of hormone randomization (for patients undergoing hormone therapy duration randomization)

    PATIENT CHARACTERISTICS:

    - No other active malignancy likely to interfere with protocol treatment or follow-up

    PRIOR CONCURRENT THERAPY:

    Inclusion criteria:

    - See Disease Characteristics

    - Co-enrollment to other trials is permitted, providing this does not interfere with the outcome measures

    - 5-α reductase inhibitors, soya, selenium, and vitamin E are acceptable non-trial therapies

    Exclusion criteria:

    - Prior hormone therapy

    - Bilateral orchidectomy

    - Prior pelvic radiotherapy

    - Neoadjuvant treatment

    - Other concurrent therapies for prostate cancer (e.g., estrogens or cytotoxic chemotherapy) prior to disease progression
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Kent and Canterbury Hospital
Canterbury
England
CT1 3NG
Royal Devon and Exeter Hospital
Exeter
England
EX2 5DW
Maidstone Hospital
Maidstone
England
ME16 9QQ
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood
England
HA6 2RN
Southampton General Hospital
Southampton
England
SO16 6YD
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Torbay Hospital
Torquay
England
TQ2 7AA
Aberdeen Royal Infirmary
Aberdeen
Scotland
AB25 2ZN
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
Velindre Cancer Center at Velindre Hospital
Cardiff
Wales
CF14 2TL
Glan Clwyd Hospital
Rhyl
Wales
LL 18 5UJ
Birmingham
B15 2TH
Cambridge
CB2 2QQ
Plymouth
PL6 8DH
Ipswich Hospital NHS Trust - Department of Clinical Neurology
Ipswich
IP4 5PD
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Guy's Hospital
London
SE1 9RT
Clinical Trials Unit; Main Hospital; Salford Rooyal NHS Foundation Trust
Salford
M6 8HD
Coventry
CV2 2DX
Doncaster
DN2 5LT
Basingstoke
RG24 9NA
Cardiff
CF14 4XW
Crewe
CW1 4QJ
Guildford
GU2 7XX
Bristol
BS10 5NB
Royal Free Hospital
London
NW1 2BU
Romford
Essex
RM7 0AG
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Lincoln County Hospital
Lincoln
England
LN2 5QY
Cancer Research Centre at Weston Park Hospital
England
S1O 2SJ
Cancer Care Centre at York Hospital
York
England
Y031 8HE
Pinderfields General Hospital
Wakefield
Scotland
WF1 4DG
Bristol
BS2 8ED
Clatterbridge Centre for Oncology NHS Trust
Birkenhead
England
CH63 4JY
Southend NHS Trust Hospital
Southend-on-Sea
England
SS0 0RY
Bradford
BD9 6RJ
Royal Bournemouth Hospital
Bournemouth
Dorset
BH7 7DW
Rotherham District General Hospital - NHS Trust
Rotherham
England
S60 2UD
Hillingdon Hospital
Uxbridge
England
UB8 3NN
Research Site
Croydon
Middlesbrough
TS4 3BW
Glasgow
G12 0YN
Site Reference ID/Investigator# 125689
Barnstaple
EX31 4JB
Stockport
SK2 7JE
Dorset Cancer Centre
Poole
England
BH15 2JB
William Harvey Hospital
Willesborough
England
TN24 0LZ
Dorset County Hospital
Dorchester
England
DT1 2JY
Princess Alexandra Hospital
Harlow
England
CM20 1QX
Royal Gwent Hospital
Wales
NP9 2UB
North Middlesex NHS Trust
London
N18 1QX
University Hospital of North Staffordshire
Stoke-on-Trent
England
ST4 7LN
Ayr Hospital
Ayr
Scotland
KA6 6DX
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Canada, United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CDR0000571528
Sponsor(s)
Medical Research Council
Key Dates

Recruitment Start Date

Oct 2007

Recruitment End Date
Date Not Available
Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

05 Oct 2007

Date updated in source

19 Feb 2012