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Low Risk Prostate CancerPhase 2PC-ARNNCT03088124

Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer

A Phase 2 study testing Apalutamide in people with Low Risk Prostate Cancer, run by Institut Paoli-Calmettes at 13 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

Many prostate cancer are slow or non progressive forms that would never impair quality or quantity of like of life if undetected. For this localized prostate cancer, the recommendation is an active surveillance, however often experienced by the patient as a lack of care. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Low Risk Prostate Cancer
What is being tested?
Apalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
13 sitesFrance
Study dates
28 Apr 2017to 8 Oct 2024
Phase
Phase 2
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Out-patient aged ≥ 18 years old
  • With life expectancy of more than 5 years
  • With ECOG performance status = 0 or 1
  • Having read, understood, signed and dated the informed consent,
  • With a Localized prostate cancer diagnozes within less than 7 months and defined by:
  • Clinical Stage: T1c or T2a
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  • Sampled biopsy with less of 3 positive cores and tumor length < 3 mm per core (<7 mm for targeted cores)
  • Gleason score < 7 (3+4 for patients >70years if small volume tumor)
  • PSA levels ≤ 10 ng/ml or PSA density <0.2ng/ml/ml
  • Clinical laboratory values at screening:
  • Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
  • Platelet count ≥100,000 x 109/µL independent of transfusion and/or growth factors within 3 months prior to randomization
  • Serum albumin ≥3.0 g/dL
  • Serum creatinine <2.0 × upper limit of normal (ULN)
  • Serum potassium ≥3.5 mmol/L
  • Serum total bilirubin ≤1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN
  • Medications known to lower the seizure threshold (see list in appendix 2) must be discontinued or substituted at least 4 weeks prior to study entry.
  • Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
  • Having accepted the principle of active surveillance
  • Who is willing to participate to the study for a minimum period of 36 months
  • Able to swallow the study drug and comply with study requirements
  • Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen.

Who cannot join

  • Prior treatment for prostate cancer with surgery or radiotherapy or including 5-alpha reductase inhibitor (finasteride or dutasteride) and antiandrogen
  • Absolute neutrophil count < 1,500/μL,
  • Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
  • Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
  • Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
  • Uncontrolled hypertension (SBP≥160 mmHg or DBP≥90 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
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  • Gastrointestinal disorder affecting absorption
  • Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
  • Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures
  • Mental deficiency or any other reason that may hinder the understanding or the strict application of the Protocol
  • Patient placed under judicial protection, tutorship, or curatorship
  • Patient unlikely to attend control visits
  • Patient currently enrolled in an investigational study or having participated to another investigational study within the past 3 months

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • Hôpital de Cannes

    Cannes, 06400

  • CHRU Hopital Edouard Herriot

    Lyon, 69437

  • Institut Paoli Calmettes

    Marseille, Bouches du Rhône, 13009

  • Clinique Beau Soleil

    Montpellier, 34070

  • Chu Hotel Dieu

    Nantes

  • Chu de Nice

    Nice

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Chu Tenon

    Paris

  • Clinique La Croix Du Sud

    Quint-Fonsegrives

  • Chu Pontchaillou

    Rennes

  • Chu Saint Etienne

    Saint-Etienne, 42055

  • CHP Saint- Grégoire

    Saint-Grégoire, 35760

  • Hia Sainte Anne

    Toulon

Other trials in France

About this study

Official title: Active Surveillance With or Without a 6 Months Apalutamide Treatment in Low Risk Prostate Cancer: A Phase II Randomized Multicenter Trial

Many prostate cancer are slow or non progressive forms that would never impair quality or quantity of like of life if undetected. For this localized prostate cancer, the recommendation is an active surveillance, however often experienced by the patient as a lack of care. Thus the introduction of new potent androgen receptor inhibitor raise the question of the benefit of early hormonal therapy in localized prostate cancers.

The aim of this study is to assess whether treatment with an oral androgen receptor inhibitor could influence the progression of localized prostate cancer and delay the time to local treatment initiation.

Read the detailed description

Several cohort studies have demonstrated that survival time in patients with untreated early stage prostate cancer is greater than 10 years in more than 70% of cases, suggesting the existence of slowly progressive or non-progressive forms of prostate cancer that would never cause any impairment to quality or quantity of life if undetected. These forms represent currently 23% to 67% of all prostate cancers. Therefore, while men's lifetime risk of prostate cancer is high (16-18%), the corresponding risk of death is only about 3%. These observations gave the opportunity to consider, near the current standard and curative treatment, an active surveillance. This therapeutically choice offers the ability to delay or avoid definitive treatment, thereby minimizing patient morbidity. Studies to date have shown that this seems to be achieved without compromising long term outcomes (progression-free survival) in appropriately selected patients. Up to one third of them receive further treatment after a median of about 2,5 years of surveillance. However, even if active surveillance is associated with the highest quality-adjusted life expectancy when compared with local treatment, active surveillance is often experienced as a lack of care, some patients undergoing surveillance experience disutility related to anxiety which can significantly affect their quality of life.

The introduction of new potent androgen receptor inhibitors able to block several steps in the androgen receptors signaling pathway, raise the question again of the benefit of early hormonal therapy in localized prostate cancers. The aim of this study is to assess whether treatment with an oral androgen receptor inhibitor could influence the progression of localized prostate cancer and delay the time to local treatment initiation.

Being tested
Apalutamide

What participants receive

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

  • ApalutamideDrug

    Also called ARN-509

    Patients will take orally everyday 240 mg of Apalutamide.

Study groups in NCT03088124
Study groupRoleWhat they receive
active surveillanceNo interventionActive surveillance without androgen deprivation
active surveillance with ApalutamideExperimentalActive surveillance during and after 6 months treatment with Apalutamide
Receives: Drug: Apalutamide

What is being measured

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

  1. Time to initiate a local treatment.

    Date of randomization and date at which local treatment is initiated

    Measured: from randomization to local treatment initiation (up to 3 years)

Secondary outcomes (4)

  1. Time to another prostate treatment initiation (excluding local treatment)

    Date of randomization, date of treatment initiation (other than local)

    Measured: from randomization to prostate treatment initiation up to 3 years

  2. Prostate Specific Antigen (PSA) and Testosterone dosages

    Biological assessment

    Measured: PSA: at screening and at 3, 6, 9,12,18, 24, 30, 36 months visits. Testosterone: at screening, 12, 24 and 36 months visits

  3. Prostate biopsy and Gleason score

    histological assessment

    Measured: At screening and at 12, 24 and 36 months visits

  4. Tumor radiological progression

    Radiological assessment by multi-parametric MRI: normal versus anormal

    Measured: At screening and at 24 months-visit

Timeline

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

  1. First posted23 Mar 2017
  2. Study start28 Apr 2017
  3. Primary completion8 Oct 2024
  4. Study completion8 Oct 2024

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03088124
Sponsor's protocol ID
PC-ARN-IPC-2015-025
Acronym
PC-ARN
Status last verified
Mar 2026
First submitted
13 Mar 2017
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apalutamide in people with Low Risk Prostate Cancer, run by Institut Paoli-Calmettes at 13 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?

The sponsor lists 23 inclusion and 13 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Time to initiate a local treatment. (time frame: from randomization to local treatment initiation (up to 3 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 NCT03088124.

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 14 Oct 2026.

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