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Gastrointestinal ComplicationsPhase 3NCT00541047

RADICALS - Radiotherapy and Androgen Deprivation In Combination After Local Surgery

A Phase 3 study testing bicalutamide, goserelin acetate and leuprolide acetate in people with Gastrointestinal Complications and Prostate Cancer, run by University College, London at 58 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 0 to 120 years, men only
What is being tested?
bicalutamide, goserelin acetate and leuprolide acetate
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,236 participants
Where
58 sitesin 2 countries
Study dates
Nov 2007to 27 Jul 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 120 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)
  • 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

Who cannot join

  • 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:
  • Prior hormone therapy
Show all 10Show fewer
  • Bilateral orchidectomy
  • Prior pelvic radiotherapy
  • Neoadjuvant treatment
  • Other concurrent therapies for prostate cancer (e.g., estrogens or cytotoxic chemotherapy) prior to disease progression

Trial locations and contacts

58 sites in 2 countries.

58 sites in 2 countries

United Kingdom53 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • William Harvey Hospital

    Ashford, England, TN24 0LZ

  • Ayr Hospital

    Ayr, Scotland, KA6 6DX

  • North Devon District Hospital

    Barnstaple, England, EX31 4JB

  • Basingstoke and North Hampshire NHS Foundation Trust

    Basingstoke, England, RG24 9NA

  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

    Birmingham, England, B15 2TH

  • Glan Clwyd Hospital

    Bodelwyddan, Wales, LL 18 5UJ

  • Royal Bournemouth Hospital

    Bournemouth, England, BH7 7DW

  • Bradford Royal Infirmary

    Bradford, England, BD9 6RJ

  • Southmead Hospital

    Bristol, England, BS10 5NB

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Addenbrooke's Hospital

    Cambridge, England, CB2 2QQ

  • Kent and Canterbury Hospital

    Canterbury, England, CT1 3NG

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • University Hospital of Wales

    Cardiff, Wales, CF14 4XW

  • Walsgrave Hospital

    Coventry, England, CV2 2DX

  • Mid Cheshire Hospitals Trust- Leighton Hopsital

    Crewe, England, CW1 4QJ

  • Mayday University Hospital

    Croydon, England

  • Doncaster Royal Infirmary

    Doncaster, England, DN2 5LT

  • Dorset County Hospital

    Dorchester, England, DT1 2JY

  • Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G12 0YN

  • St. Luke's Cancer Centre at Royal Surrey County Hospital

    Guildford, England, GU2 7XX

  • Princess Alexandra Hospital

    Harlow, England, CM20 1QX

  • Ipswich Hospital

    Ipswich, England, IP4 5PD

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Lincoln County Hospital

    Lincoln, England, LN2 5QY

  • Helen Rollason Cancer Care Centre at North Middlesex Hospital

    London, England, N18 1QX

  • University College Hospital

    London, England, NW1 2BU

  • Guy's Hospital

    London, England, SE1 9RT

  • Royal Marsden - London

    London, England, SW3 6JJ

  • Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Clatterbridge Centre for Oncology

    Manchester, England, CH63 4JY

  • Christie Hospital

    Manchester, England, M20 4BX

  • James Cook University Hospital

    Middlesbrough, England, TS4 3BW

  • Royal Gwent Hospital

    Newport, Wales, NP9 2UB

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Derriford Hospital

    Plymouth, England, PL6 8DH

  • Dorset Cancer Centre

    Poole Dorset, England, BH15 2JB

  • Queen's Hospital

    Romford, England, RM7 0AG

  • Rotherham General Hospital

    Rotherham, England, S60 2UD

  • Hope Hospital

    Salford, England, M6 8HD

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • Stepping Hill Hospital

    Stockport, England, SK2 7JE

  • University Hospital of North Staffordshire

    Stoke-on-Trent, England, ST4 7LN

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

  • Torbay Hospital

    Torquay, England, TQ2 7AA

  • Hillingdon Hospital

    Uxbridge, England, UB8 3NN

  • Pinderfields General Hospital

    Wakefield, Scotland, WF1 4DG

  • Southend University Hospital NHS Foundation Trust

    Westcliff-on-Sea, England, SS0 0RY

  • Cancer Care Centre at York Hospital

    York, England, Y031 8HE

Other trials in United Kingdom

Canada5 sites

  • British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Ottawa Health Research Institute

    Ottawa, Ontario, K1Y 4E9

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (RADICALS)

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.

Read the detailed description

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.

Being tested
bicalutamide, goserelin acetate, leuprolide acetate, adjuvant therapy, quality-of-life assessment
Keywords
sexual dysfunction, urinary complications, gastrointestinal complications, adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
Medical subject headings
Prostatic Neoplasms, Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bicalutamideDrug

  • goserelin acetateDrug

  • leuprolide acetateDrug

  • adjuvant therapyProcedure or surgery

  • quality-of-life assessmentProcedure or surgery

  • radiation therapyRadiation

Study groups in NCT00541047
Study groupRoleWhat they receive
RADICALS-RT: Early RTExperimentalNot described
Receives: Procedure: adjuvant therapy; Procedure: quality-of-life assessment; Radiation: radiation therapy
RADICALS-RT: Salvage RTExperimentalNot described
Receives: Procedure: adjuvant therapy; Procedure: quality-of-life assessment; Radiation: radiation therapy
RADICALS-HD: Radiotherapy AloneExperimentalNot described
Receives: Procedure: adjuvant therapy; Radiation: radiation therapy
RADICALS-HD: Radiotherapy + 6 monthsExperimentalNot described
Receives: Drug: bicalutamide; Drug: goserelin acetate; Drug: leuprolide acetate; Procedure: adjuvant therapy; Radiation: radiation therapy
RADICALS-HD: Radiotherapy + 24 monthsExperimentalNot described
Receives: Drug: bicalutamide; Drug: goserelin acetate; Drug: leuprolide acetate; Procedure: adjuvant therapy; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-specific survival (i.e., death due to prostate cancer) (RADICALS-HD)

    Measured: up 12 years

  2. Freedom from distant metastases (any distance metastases or prostate cancer death) (RADICALS-RT)

    Measured: up 12 years

Secondary outcomes (7)

  1. Freedom from treatment failure

    Measured: up 12 years

  2. Clinical progression-free survival

    Measured: up 12 years

  3. Overall survival

    Measured: up 12 years

  4. Non-protocol hormone therapy

    Measured: up 12 years

  5. Treatment toxicity

    Measured: up 12 years

  6. Patient reported outcomes - EQ5D

    Measured: up 12 years

  7. Freedom from biochemical progression (RADICALS-RT)

    Measured: up 12 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2007 (estimated)
  2. Study startNov 2007
  3. Primary completion27 Jul 2022
  4. Study completion27 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
4,236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00541047
Sponsor's protocol ID
CDR0000571528
Other IDs
MRC-RADICALS-PR10, ISRCTN40814031, 2006-000205-34, NCT00541047, 00316/0223/001-0001, PR13
Status last verified
Nov 2023
First submitted
5 Oct 2007
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: Data can be shared on request via emailing mrcctu.radical@ucl.ac.uk

Publications

  • Parker CC, Clarke NW, Catton C, Kynaston H, Cook A, Cross W, Davidson C, Goldstein C, Logue J, Maniatis C, Petersen PM, Neville P, Payne H, Persad R, Pugh C, Stirling A, Saad F, Parulekar WR, Parmar MKB, Sydes MR. RADICALS-HD: Reflections before the Results are Known. Clin Oncol (R Coll Radiol). 2022 Sep;34(9):593-597. doi: 10.1016/j.clon.2022.06.004. Epub 2022 Jul 6. No abstract available.

    PubMed 35810050

  • Parker CC, Clarke NW, Cook AD, Kynaston HG, Petersen PM, Catton C, Cross W, Logue J, Parulekar W, Payne H, Persad R, Pickering H, Saad F, Anderson J, Bahl A, Bottomley D, Brasso K, Chahal R, Cooke PW, Eddy B, Gibbs S, Goh C, Gujral S, Heath C, Henderson A, Jaganathan R, Jakobsen H, James ND, Kanaga Sundaram S, Lees K, Lester J, Lindberg H, Money-Kyrle J, Morris S, O'Sullivan J, Ostler P, Owen L, Patel P, Pope A, Popert R, Raman R, Roder MA, Sayers I, Simms M, Wilson J, Zarkar A, Parmar MKB, Sydes MR. Timing of radiotherapy after radical prostatectomy (RADICALS-RT): a randomised, controlled phase 3 trial. Lancet. 2020 Oct 31;396(10260):1413-1421. doi: 10.1016/S0140-6736(20)31553-1. Epub 2020 Sep 28.

    PubMed 33002429

  • Vale CL, Fisher D, Kneebone A, Parker C, Pearse M, Richaud P, Sargos P, Sydes MR, Brawley C, Brihoum M, Brown C, Chabaud S, Cook A, Forcat S, Fraser-Browne C, Latorzeff I, Parmar MKB, Tierney JF; ARTISTIC Meta-analysis Group. Adjuvant or early salvage radiotherapy for the treatment of localised and locally advanced prostate cancer: a prospectively planned systematic review and meta-analysis of aggregate data. Lancet. 2020 Oct 31;396(10260):1422-1431. doi: 10.1016/S0140-6736(20)31952-8. Epub 2020 Sep 28.

    PubMed 33002431

  • Parker CC, Clarke NW, Cook AD, Kynaston H, Catton CN, Cross WR, Petersen PM, Persad RA, Saad F, Bower LC, Logue J, Payne H, Forcat S, Goldstein C, Murphy C, Anderson J, Barkati M, Bottomley DM, Branagan J, Choudhury A, Chung PWM, Cogley L, Goh CL, Hoskin P, Khoo V, Malone SC, Masters L, Morris SL, Nabid A, Ong AD, Raman R, Tarver KL, Tree AC, Worlding J, Wylie JP, Zarkar AM, Parulekar WR, Parmar MKB, Sydes MR; RADICALS investigators. Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial. Lancet. 2024 Jun 1;403(10442):2405-2415. doi: 10.1016/S0140-6736(24)00548-8. Epub 2024 May 16.

    PubMed 38763154

  • Parker CC, Kynaston H, Cook AD, Clarke NW, Catton CN, Cross WR, Petersen PM, Persad RA, Pugh CA, Saad F, Logue J, Payne H, Bower LC, Brawley C, Rauchenberger M, Barkati M, Bottomley DM, Brasso K, Chung HT, Chung PWM, Conroy R, Falconer A, Ford V, Goh CL, Heath CM, James ND, Kim-Sing C, Kodavatiganti R, Malone SC, Morris SL, Nabid A, Ong AD, Raman R, Rodda S, Wells P, Worlding J, Parulekar WR, Parmar MKB, Sydes MR; RADICALS investigators. Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial. Lancet. 2024 Jun 1;403(10442):2416-2425. doi: 10.1016/S0140-6736(24)00549-X. Epub 2024 May 16.

    PubMed 38763153

  • Parker CC, Petersen PM, Cook AD, Clarke NW, Catton C, Cross WR, Kynaston H, Parulekar WR, Persad RA, Saad F, Bower L, Durkan GC, Logue J, Maniatis C, Noor D, Payne H, Anderson J, Bahl AK, Bashir F, Bottomley DM, Brasso K, Capaldi L, Chung C, Cooke PW, Donohue JF, Eddy B, Heath CM, Henderson A, Henry A, Jaganathan R, Jakobsen H, James ND, Joseph J, Lees K, Lester J, Lindberg H, Makar A, Morris SL, Oommen N, Ostler P, Owen L, Patel P, Pope A, Popert R, Raman R, Ramani V, Roder A, Sayers I, Simms M, Srinivasan V, Sundaram S, Tarver KL, Tran A, Wells P, Wilson J, Zarkar AM, Parmar MKB, Sydes MR; RADICALS investigators. Timing of radiotherapy (RT) after radical prostatectomy (RP): long-term outcomes in the RADICALS-RT trial (NCT00541047). Ann Oncol. 2024 Jul;35(7):656-666. doi: 10.1016/j.annonc.2024.03.010. Epub 2024 Apr 5.

    PubMed 38583574

  • Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29.

    PubMed 38421243

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bicalutamide, goserelin acetate and leuprolide acetate in people with Gastrointestinal Complications and Prostate Cancer, run by University College, London at 58 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-specific survival (i.e., death due to prostate cancer) (RADICALS-HD) (time frame: up 12 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00541047, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.

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