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Prostate CancerPhase 3NCT00423475

Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

A Phase 3 study testing goserelin acetate, adjuvant therapy and radiation therapy in people with Prostate Cancer, run by UNICANCER at 31 sites in France.

Completed

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

Official record
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Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
goserelin acetate, adjuvant therapy and radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
743 participants
Where
31 sitesFrance
Study dates
Oct 2006to Mar 2015
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 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Localized disease treated with surgery only
  • pT2, pT3, or pT4
  • pN0 or pNx
  • No clinical signs of progressive disease
  • Prostate-specific antigen (PSA) meeting the following criteria:
  • PSA ≤ 0.1 ng/mL after prostatectomy
  • PSA ≥ 0.2 ng/mL and < 2 ng/mL at study entry

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 10 years
  • No other cancer in the past 5 years except for treated basal cell skin cancer
  • No known pituitary gland adenoma
  • No uncontrolled hypertension (i.e., blood pressure ≥ 160 mm Hg systolic and/or 90 mm Hg diastolic)
  • No geographical, social, or psychological condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior hormonal therapy
  • No prior pelvic radiotherapy
  • No prior surgical or chemical castration
  • At least 6 months since surgery for biological recurrence
  • No other concurrent anticancer therapy

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

France31 sites

  • Centre Paul Papin

    Angers, 49036

  • Institut Sainte Catherine

    Avignon, 84082

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Hopital Louis Pasteur

    Colmar, 68024

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94000

  • Centre Hospitalier Intercommunal des Alpes du Sud

    Gap, 05007

  • Centre Oscar Lambret

    Lille, 59020

  • Polyclinique des Quatre Pavillons

    Lormont, 33310

  • Centre Leon Berard

    Lyon, 69373

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200

  • Centre Antoine Lacassagne

    Nice, 06088

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital Saint Joseph

    Paris, 75674

  • Hopital Tenon

    Paris, 75970

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Poitiers

    Poitiers, 86021

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugene Marquis

    Rennes, 35064

  • CHG Roanne

    Roanne, F-42300

  • Clinique Armoricaine De Radiologie

    Saint-Brieuc, F-22015

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • Clinique Mutualiste

    Saint-Etienne, 42013

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42270

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Marie Curie

    Valence, 26000

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: Phase III Randomized Study of Adjuvant Radiotherapy With Versus Without Concurrent Goserelin in Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens. Giving radiation therapy with or without goserelin after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without goserelin in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy and goserelin to see how well they work compared with radiation therapy alone in treating patients who have undergone surgery for recurrent or refractory prostate cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the efficacy of adjuvant radiotherapy with vs without concurrent goserelin, in terms of biological and/or clinical progression-free survival, in patients who have undergone surgery for recurrent or refractory prostate cancer.

Secondary

  • Compare overall survival of patients treated with these regimens.
  • Compare metastases-free survival of patients treated with these regimens.
  • Compare the immediate and delayed toxicities of these regimens.
  • Compare the delay in reaching the prostate-specific antigen nadir in patients treated with these regimens.
  • Compare the quality of life at 1 and 5 years after radiotherapy in these patients.
  • Compare the functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over.

OUTLINE: This is an open-label, randomized, parallel-group, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
  • Arm II: Patients undergo radiotherapy as in arm I. Patients also receive goserelin subcutaneously on day 1 and again 3 months later.

Quality of life is assessed periodically.

After completion of study therapy, patients are followed periodically for 10 years.

PROJECTED ACCRUAL: A total of 466 patients will be accrued for this study.

Conditions
Prostate Cancer
Being tested
goserelin acetate, adjuvant therapy, radiation therapy
Keywords
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, recurrent prostate cancer, stage IV prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • goserelin acetateDrug

    Also called ZOLADEX

  • adjuvant therapyProcedure or surgery

  • radiation therapyRadiation

Study groups in NCT00423475
Study groupRoleWhat they receive
IActive comparatorExclusive Radiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
Receives: Procedure: adjuvant therapy; Radiation: radiation therapy
IIExperimentalRadiation Therapy 66 Gy (prostatic bed) / 46 Gy (Pelvis with lymph nod involvement) and GOSERELIN ACETATE in treating patients who have undergone surgery for recurent or refractory Prostate Cancer
Receives: Drug: goserelin 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. Progression-free (biological and/or clinical) survival

    Measured: 3.5 years

Secondary outcomes (6)

  1. Overall survival

    Measured: not yet evaluable

  2. Metastases-free survival

    Measured: not yet evaluable

  3. Immediate and delayed toxicities

    Measured: not yet evaluable

  4. Delay in reaching the prostate-specific antigen nadir

    Measured: not yet evaluable

  5. Quality of life at 1 and 5 years after radiotherapy

    Measured: not yet evaluable

  6. Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over

    Measured: not yet evaluable

Timeline

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

  1. First posted18 Jan 2007 (estimated)
  2. Study startOct 2006
  3. Primary completionMar 2015

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
Parallel groups
Masking
None (open label)
Enrolment
743 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00423475
Sponsor's protocol ID
GETUG-AFU 16 - UC-0160/0504
Other IDs
EUDRACT-2005-005165-11, CDR0000523446
Status last verified
May 2018
First submitted
16 Jan 2007
Last updated
17 May 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Carrie C, Magne N, Burban-Provost P, Sargos P, Latorzeff I, Lagrange JL, Supiot S, Belkacemi Y, Peiffert D, Allouache N, Dubray BM, Servagi-Vernat S, Suchaud JP, Crehange G, Guerif S, Brihoum M, Barbier N, Graff-Cailleaud P, Ruffion A, Dussart S, Ferlay C, Chabaud S. Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial. Lancet Oncol. 2019 Dec;20(12):1740-1749. doi: 10.1016/S1470-2045(19)30486-3. Epub 2019 Oct 16.

    PubMed 31629656

  • Carrie C, Hasbini A, de Laroche G, Richaud P, Guerif S, Latorzeff I, Supiot S, Bosset M, Lagrange JL, Beckendorf V, Lesaunier F, Dubray B, Wagner JP, N'Guyen TD, Suchaud JP, Crehange G, Barbier N, Habibian M, Ferlay C, Fourneret P, Ruffion A, Dussart S. Salvage radiotherapy with or without short-term hormone therapy for rising prostate-specific antigen concentration after radical prostatectomy (GETUG-AFU 16): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol. 2016 Jun;17(6):747-756. doi: 10.1016/S1470-2045(16)00111-X. Epub 2016 May 6.

    PubMed 27160475

  • Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prise E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.

    PubMed 25592642

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing goserelin acetate, adjuvant therapy and radiation therapy in people with Prostate Cancer, run by UNICANCER at 31 sites in France.

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

Who may be eligible to take part?

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 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in France. 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?

Progression-free (biological and/or clinical) survival (time frame: 3.5 years). 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 NCT00423475, which also lists 3 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 17 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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