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Prostatic Neoplasms, Locally AdvancedPhase 3NCT01122121

Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer

A Phase 3 study testing Leuprorelin SR, Radiotherapy and Flutamide in people with Prostatic Neoplasms, Locally Advanced, run by Takeda at 1 site 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

The purpose of this study is to compare the efficacy and safety of combined radiotherapy and hormone therapy and hormone therapy alone in the treatment of clinically locally advanced prostate cancer (T3-T4 or pT3 on biopsy, N0, M0). Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostatic Neoplasms, Locally Advanced
What is being tested?
Leuprorelin SR, Radiotherapy and Flutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
273 participants
Where
1 siteFrance
Study dates
Mar 2000to Jun 2009
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 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed locally advanced adenocarcinoma of the prostate, graded: T3 or T4 or pT3 on biopsies (presence of tumour tissue in periprostatic fat observed on biopsies), N0 (absence of metastatic), M0 (no distant metastases detectable on the following examinations: bone scan, chest x-ray, abdominal and pelvic ultrasound).
  • Patient in whom the prostatic adenocarcinoma has received no prior treatment of any type, with the possible exception of transurethral resection due to obstructive symptoms.
  • Patient with a Karnofsky index greater than or equal to (≥) 70.
  • Patient aged under 80 years on the randomization date.
  • Patient with a life expectancy of at least 7 years.
  • Patient who, after having received clear information, gave his written consent to participate and cooperate in the study.
  • Patient for whom a recent blood test (less than [<] 2 months) has not revealed elevated transaminases ≥ 3 times the normal laboratory range.

Who cannot join

  • Patient incapable of understanding the information supplied concerning the study or of giving his consent, or having refused to sign the informed consent form,
  • Patient for whom there is a risk that follow-up in compliance with the conditions stipulated by the protocol will not be possible,
  • Patient having already received prior treatment for prostate cancer, excluding transurethral resection of the prostate to relieve obstruction,
  • Patient having undergone surgical castration, or with a history of bilateral adrenalectomy or hypophysectomy,
  • Patient having had another cancer within the previous 5 years (including carcinoma in situ of the bladder) excluding basocellular epithelioma or carcinoma in situ (other than in the bladder),
  • Patient with lymph node or metastatic spread of the prostatic adenocarcinoma suspected on imaging,
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  • Patient with a non-controlled severe active disease,
  • Patient with a contraindication to external prostatic radiotherapy,
  • Patient receiving or having received another experimental treatment within 3 months prior to inclusion in the study,
  • Patient with impaired liver function or elevated transaminases ≥3 times the normal laboratory range.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Clinique Mutualiste

    Saint-Etienne, 42013

Other trials in France

About this study

Official title: Comparative Efficacy and Safety of Combined Radiotherapy and Adjuvant Hormone Therapy (Leuprorelin SR 11.25 mg) and Hormone Therapy Alone (Leuprorelin SR 11.25 mg) in Locally Advanced Prostate Cancer (T3-T4 or pT3 on Biopsy, N0, M0)

The purpose of this study is to compare the efficacy and safety of combined radiotherapy and hormone therapy and hormone therapy alone in the treatment of clinically locally advanced prostate cancer (T3-T4 or pT3 on biopsy, N0, M0).

Read the detailed description

The drug being tested in this study is called leuprorelin SR. Leuprorelin SR is being tested to treat people who have prostate cancer. This study will look at the overall survival of people who take leuprorelin SR in addition to radiation therapy compared to those who take only leuprorelin SR.

The study will enroll approximately 273 patients. Participants will be randomly assigned to one of the two treatment groups.

  • Combined Radiotherapy and Hormone Therapy
  • Hormone Therapy alone. All participants will receive leuprorelin injection every 3 months and flutamide tablets thrice daily for first 30 days as part of hormone therapy. Participants randomized to combined radiotherapy and hormone therapy group, will also receive radiotherapy 70 +/- 4 Gy in 35 fractions at a rate of 5 fractions of 2 Gy per week.

This multi-center trial will be conducted in France and Tunisia. The overall time to participate in this study is 8 years. The scheduled duration of hormone therapy was 3 years in both arms, with an additional treatment-free follow-up period of 2 years i.e. a total follow-up period of 5 years. Post-protocol collection of information relative to survival will be performed after the end the 5-year follow-up period.

Being tested
Leuprorelin SR, Radiotherapy, Flutamide
Keywords
Drug Therapy, Radiotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Leuprorelin SRDrug

    Also called ENANTONE SR

    Leuprorelin SR injection

  • RadiotherapyRadiation

    Radiotherapy 70 +/- 4 Gy

  • FlutamideDrug

    Flutamide tablets

Study groups in NCT01122121
Study groupRoleWhat they receive
Combined Radiotherapy and Hormone TherapyExperimentalLeuprorelin 11.25 milligram (mg) sustained release (SR), injection, subcutaneously, once every 3 months up to 3 years and flutamide 250 mg, tablet, orally, thrice daily for 30 days from the first dose of leuprorelin. Radiotherapy 70 +/- 4 Gray (Gy) in 35 fractions at a rate of 5 fractions of 2 Gy per week up to 3 years. An interval of a maximum of 2 weeks is authorized between radiation of the pelvis with 50 Gy (±4) (5 weeks) and radiation of the prostate with an additional 20 Gy.
Receives: Drug: Leuprorelin SR; Radiation: Radiotherapy; Drug: Flutamide
Hormone Therapy aloneActive comparatorLeuprorelin 11.25 mg SR, injection, subcutaneously, once every 3 months up to 3 years and flutamide 250 mg, tablet, orally, thrice daily for 30 days from the first dose of leuprorelin.
Receives: Drug: Leuprorelin SR; Drug: Flutamide

What is being measured

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

  1. Progression-free survival at 5 years

    PFS=time from randomization to first documentation of progression (death, biological progression or clinical progression). PFS at Year 5=probability of participants' PFS at Year 5. Biological progression definition I: halfway point between nadir and first rise with prostate-specific antigen (PSA) ≥1 nanogram per milliliter (ng/mL) signifying progression and date of introduction of prostate treatment for all participants, including those leaving prematurely for reason other than progression/death; definition II: first date when PSA=nadir+2 ng/mL and date of introduction of prostate treatment, for participants leaving prematurely for reason other than progression/death. Clinical progression: local clinical progression->50% increase in prostate volume relative to lowest volume, recurrence of palpable prostatic tumor after complete regression, positive biopsy; locoregional progression=pelvic regional lymph node lesion development; metastatic progression=distant lesions identification.

    Measured: Year 5

Secondary outcomes (7)

  1. Time to Biological Progression

    Biological progression as per definition I is defined as halfway point between nadir and first rise with PSA greater than or equal to (≥) 1 ng/mL signifying progression and date of introduction of prostate treatment for all participants, including those leaving prematurely for reason other than progression/death; and as per definition II, it is defined as first date when PSA=nadir+2 ng/mL and date of introduction of prostate treatment, for participants leaving prematurely for reason other than progression/death. Time to onset of biological progression will be performed using the Kaplan- Meier method taking into account the date of onset of the first biological progression. The participants will be censored on the date of death, lost to follow-up or living without biological progression on the date of the last news.

    Measured: Baseline up to Year 5

  2. Time to Clinical Progression

    Clinical progression is based on three parameters: local clinical progression which is defined as greater than (>) 50 percent (%) increase in prostate volume relative to lowest volume, recurrence of palpable prostatic tumor after complete regression, positive biopsy; locoregional progression which is defined as pelvic regional lymph node lesion development; and metastatic progression which is defined as distant lesions identification. Time to onset of clinical progression will be performed using the Kaplan-Meier method based on the date of onset of the first progression among local, locoregional or metastatic clinical progressions.

    Measured: Baseline up to Year 5

  3. Overall Survival

    Overall survival will be measured as the time from the date of randomization to the date of death. Participants will be censored in case of lost to follow-up or alive on the date of the last news.

    Measured: Baseline up to Year 5

  4. Time to Locoregional Progression

    Locoregional progression is defined as the development of pelvic regional lymph node lesion(s) identified by computed tomography (CT) scan or ultrasound and confirmed by biopsy in the absence of any other signs of progression. It will be performed using the Kaplan-Meier method taking into account the date of onset of locoregional progression.

    Measured: Baseline up to Year 5

  5. Time to Onset of Metastatic Progression

    Metastatic progression is defined as identification of distant lesions. Time to onset of metastatic progression will be performed using the Kaplan-Meier method taking into account the date of onset of the first metastatic progression. The participants will be censored in case of death, lost to follow-up or alive without metastatic progression on the date of the last news.

    Measured: Baseline up to Year 5

  6. Specific Survival

    Analysis of specific survival using the Kaplan-Meier method takes into account the dates of death linked to the disease. The participants will be censored in case of death, lost to follow-up or alive on the date of the last news.

    Measured: Baseline up to Year 5

  7. Number of Deaths linked to the disease

    Measured: Baseline up to Year 5

Timeline

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

  1. First posted13 May 2010 (estimated)
  2. Study startMar 2000
  3. Primary completionDec 2008
  4. Study completionJun 2009

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
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01122121
Sponsor's protocol ID
TAP III/98/032
Other IDs
U1111-1169-6728
Status last verified
Jul 2015
First submitted
7 May 2010
Last updated
29 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Sargos P, Mottet N, Bellera C, Richaud P. Long-term androgen deprivation, with or without radiotherapy, in locally advanced prostate cancer: updated results from a phase III randomised trial. BJU Int. 2020 Jun;125(6):810-816. doi: 10.1111/bju.14768. Epub 2020 Mar 2.

    PubMed 30946523

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Leuprorelin SR, Radiotherapy and Flutamide in people with Prostatic Neoplasms, Locally Advanced, run by Takeda at 1 site in France.

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 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 survival at 5 years (time frame: Year 5). 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 NCT01122121, which also lists 1 linked publication.

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 29 Jul 2015.

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