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Adenocarcinoma of ProstatePhase 3PEACE2NCT01952223

A Phase III of Cabazitaxel and Pelvic Radiotherapy in Localized Prostate Cancer and High-risk Features of Relapse

A Phase 3 study testing Cabazitaxel, Pelvic radiotherapy and prostate radiotherapy in people with Adenocarcinoma of Prostate and Progression of Prostate Cancer, run by UNICANCER at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of this study is to assess the effect of neoadjuvant cabazitaxel and pelvic radiotherapy in combination with androgen deprivation therapy (ADT)-radiotherapy on clinical progression-free survival in patients with high-risk localized prostate cancer (with a stringent selection of patients with at least 2… Read more about this study

Who is it for?
Ages 18 to 75 years, men only
What is being tested?
Cabazitaxel, Pelvic radiotherapy and prostate radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
761 participants
Where
1 siteFrance
Study dates
Dec 2013to Jul 2041
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Any T histologically confirmed adenocarcinoma of the prostate
  • No clinically or radiologically suspected metastases, including no enlarged pelvic lymph nodes (> 1 cm in small diameter)
  • Gleason score ≥ 6
  • Meets at least 2 of the following criteria for high-risk:
  • Gleason score ≥ 8
  • T3 or T4 disease (T3 defined by MRI is acceptable)
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  • Prostate-specific antigen equal or greater than 20 ng/mL
  • No prior treatment for prostate cancer except lymph node dissection (patients with pN- and pN+ disease can be accrued) or ADT (started up to 6 weeks before randomization).
  • 18 years ≤ Age ≤ 75 years
  • Eastern Cooperative Oncology Group (ECOG) 0-1 performance status
  • Expected life expectancy of more than 10 years
  • Absolute neutrophil count ≥ 1.5 x 10⁹/L
  • Platelets ≥ 100 x 10⁹/L
  • Hb ≥ 9.0 g/dL
  • Hepatic function: serum bilirubin ≤ 1 upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Renal function (creatinine clearance using the Chronic Kidney Disease Epidemiology group (CKD-EPI) formula ≥ 60 mL/min).
  • Potentially reproductive patients must agree to use an effective contraceptive method while on treatment and for 6 months after the final dose of investigational product.
  • Patients must be affiliated to a Social Security System or should fulfill the country legislation for clinical trials.
  • Patients who have received the information sheet and signed the informed consent form.
  • Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Who cannot join

  • Patients with other known concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as:
  • infection,
  • cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, left ventricular ejection fraction (LVEF) > grade 2,
  • uncontrolled diabetes mellitus,
  • current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment),
  • renal disease,
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  • active GI tract ulceration, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded,
  • known severely impaired lung function (spirometry and diffusing capacity of the lungs for carbon monoxide (DLCO) 70% or less of normal and O2 saturation of 88% or less at rest on room air).
  • Other prior malignancy within the last 5 years, except basal cell skin cancer
  • Physical or psychological condition that would preclude study compliance
  • Hypersensitivity to cabazitaxel (hypersensitivity reaction ≥grade 3), to other taxanes, or to any excipients of the formulation including polysorbate 80
  • Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
  • Patients who received any other investigational drugs within the 30 days prior to the start of cabazitaxel.
  • Previous pelvic irradiation that make prostatic irradiation impossible
  • Severe GI disorders precluding pelvic irradiation
  • Patients already included in another therapeutic trial involving an experimental drug
  • Individual deprived of liberty or placed under the authority of a tutor.
  • Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix 6). A one week wash-out period is necessary for patients who are already on these treatments

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

Official title: A Randomized Phase III, Factorial Design, of Cabazitaxel and Pelvic Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse

The objective of this study is to assess the effect of neoadjuvant cabazitaxel and pelvic radiotherapy in combination with androgen deprivation therapy (ADT)-radiotherapy on clinical progression-free survival in patients with high-risk localized prostate cancer (with a stringent selection of patients with at least 2 high-risk features), in a 2 by 2 factorial trial.

Read the detailed description

Eligible patients can be randomized via the TENALEA web site process that insure centralization of the randomization.

Randomization will be performed according a 1:1:1:1 ratio. The randomization will be stratified (by minimization) according to the number of risk factors (2 vs.3), disease extent (pN- vs. pN+ vs. pNx) and the site.

The minimization will be defined with a similar weight for all 3 stratification factors and a probability of assigning the treatment that minimize the imbalance equal to 80%.

The main analysis of progression-free survival (PFS) will be event driven (> 247 events). It will likely be performed when the median follow-up is approximately 6 years, i.e. 4 years after the inclusion of the last patient (assuming an accrual of 4 years).

A long-term analysis (allowing for robust PFS and overall survival (OS) data) will also be performed when the follow-up is approximately 10 years. Its exact timing will be discussed with the steering committee and the IDMC.

An interim analysis of the primary endpoint is planned. This interim analysis will be performed at a 0.001 level (Peto) after 50% of the events i.e. 125 have occurred.

For each comparison (CT comparison and pelvic RT comparison) the two PFS curves will be compared using the adjusted logrank test (bilateral test): adjusted logrank on pelvic RT for the CT comparison and on CT for the pelvic RT comparison. A multivariate analysis using the Cox model will also be used.

An Independent Data Monitoring Committee (IDMC) composed of international experts (at least 2 physicians and 1 statistician) will be selected.

For safety purpose, the IDMC will meet after the inclusion of 20 patients (and then again after accrual of 50 patients) in the cabazitaxel and pelvic radiotherapy arm, to assess tolerance, (i.e. after the inclusion of approximately 80 and then 200 patients in the trial). Depending on the results of this feasibility phase and of any new relevant clinical results in such a population, the remaining patients (n=848) will be enrolled.

During this second phase, the IDMC will then meet every two years approximately during accrual to carefully assess accrual rate and toxicity and examine the efficacy interim analysis results in the light of the results of similar trials.

Being tested
Cabazitaxel, Pelvic radiotherapy, prostate radiotherapy
Keywords
adenocarcinoma, prostate, relapse, Radiotherapy, Androgen Deprivation Therapy, Cabazitaxel
Medical subject headings
Adenocarcinoma, Recurrence

What participants receive

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

  • CabazitaxelDrug

    Also called jevtana

    Cabazitaxel administered at 25 mg/m² as a 1 hour intravenous infusion every 3 weeks (1 cycle = 21 days) for 4 cycles

  • Pelvic radiotherapyRadiation

    Prostate+pelvic RT (2 Gy fractions, 5 times per week):

    • Phase 1: pelvic radiotherapy (prostate, seminal vesicles, ilio-obturator, presacral lymph nodes) (46 or 50 Gy according to the center)
    • Phase 2: prostate-only boost (EBRT) up to 74-78 Gy

  • prostate radiotherapyRadiation

    Prostate-only RT (2 Gy fractions, 5 times per week):

    • Phase 1: prostate + seminal vesicle radiotherapy (46 or 50 Gy according to the center)
    • Phase 2: prostate-only boost (EBRT) up to 74-78 Gy
Study groups in NCT01952223
Study groupRoleWhat they receive
ADT + pelvic RTExperimentalADT for a total duration of 3 years i.e. luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist +/-Peripheral anti-androgen Pelvic RT (by IMRT or IGRT protocol): * Phase 1: pelvic radiotherapy (prostate, seminal vesicles, ilio-obturator, presacral lymph nodes) (46 or 50 Gy according to the center) * Phase 2: prostate-only boost (EBRT) up to 74-78 Gy
Receives: Radiation: Pelvic radiotherapy
ADT + Cabazitaxel + prostate RTExperimentalADT Cabazitaxel: 4 CT cycles Prostate-only RT (IMRT or IGRT): * Phase 1: prostate + seminal vesicle radiotherapy (46 or 50 Gy according to the center) * Phase 2: prostate-only boost (EBRT) up to 74-78 Gy
Receives: Drug: Cabazitaxel; Radiation: prostate radiotherapy
ADT + cabazitaxel + pelvic RTExperimentalADT Cabazitaxel: 4 CT cycles Pelvic RT (IMRT or IGRT): * Phase 1: pelvic radiotherapy (prostate, seminal vesicles, ilio-obturator, presacral lymph nodes) (46 or 50 Gy according to the center) * Phase 2: prostate-only boost (EBRT) up to 74-78 Gy
Receives: Drug: Cabazitaxel; Radiation: Pelvic radiotherapy
ADT + prostate radiotherapyActive comparatorADT for a total duration of 3 years: LHRH agonist or LHRH antagonist +/- anti-androgen Prostate-only RT (IMRt or IGRT): * Phase 1: prostate + seminal vesicle radiotherapy (46 or 50 Gy according to the center) * Phase 2: prostate-only boost (EBRT) up to 74-78 Gy
Receives: Radiation: prostate radiotherapy

What is being measured

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

  1. progression free survival

    Measured: 10 years

Secondary outcomes (11)

  1. prostate-specific antigen response at 3 months

    Measured: 10 years

  2. biochemical progression-free survival

    Measured: 10 years

  3. metastases-free survival

    Measured: 10 years

  4. local relapse-free survival

    Measured: 10 years

  5. overall survival

    Measured: 10 years

  6. prostate cancer-specific survival

    Measured: 10 years

  7. acute toxicity

    Measured: 10 years

  8. impact of treatment on serum testosterone

    Measured: 10 years

  9. long-term toxicity

    Measured: 10 years

  10. predictive biomarkers of treatment efficacy

    Measured: 10 years

  11. quality of life

    Measured: 10 years

Timeline

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

  1. First posted27 Sep 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2025 (estimated)
  4. Study completionJul 2041 (estimated)

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
761 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01952223
Sponsor's protocol ID
GETUG-AFU 23 - UC-0160/1202
Other IDs
2012-000566-38
Acronym
PEACE2
Status last verified
Jun 2025
First submitted
24 Sep 2013
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cabazitaxel, Pelvic radiotherapy and prostate radiotherapy in people with Adenocarcinoma of Prostate and Progression of Prostate Cancer, run by UNICANCER 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 20 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2025. 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?

This study is still under way. Results are not available in the source record yet.

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 (time frame: 10 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 NCT01952223.

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 30 Jul 2025.

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