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

NCT03088124 | Completed Phase 2

• 1 other identifier: PC-ARN IPC-2015-025
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 13

Brief 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. 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.

Conditions

Low Risk Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Time to initiate a local treatment.

  Date of randomization and date at which local treatment is initiated

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

Secondary Outcomes (4)

• Time to another prostate treatment initiation (excluding local treatment)

  from randomization to prostate treatment initiation up to 3 years

• Prostate Specific Antigen (PSA) and Testosterone dosages

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

• Prostate biopsy and Gleason score

  At screening and at 12, 24 and 36 months visits

• Tumor radiological progression

  At screening and at 24 months-visit

Study Arms (2)

active surveillance

NO INTERVENTION

Active surveillance without androgen deprivation

active surveillance with Apalutamide

EXPERIMENTAL

Active surveillance during and after 6 months treatment with Apalutamide

Drug: Apalutamide

Interventions

Apalutamide DRUG

Patients will take orally everyday 240 mg of Apalutamide.

Also known as: ARN-509

active surveillance with Apalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.: collaborator
• Institut Paoli-Calmettes: lead

Study Sites (13)

Institut Paoli Calmettes

Marseille, Bouches du Rhône, 13009, France

Location

Hôpital de Cannes

Cannes, 06400, France

Location

CHRU Hopital Edouard Herriot

Lyon, 69437, France

Location

Clinique Beau Soleil

Montpellier, 34070, France

Location

Chu Hotel Dieu

Nantes, France

Location

Chu de Nice

Nice, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Chu Tenon

Paris, France

Location

Clinique La Croix Du Sud

Quint-Fonsegrives, France

Location

Chu Pontchaillou

Rennes, France

Location

Chu Saint Etienne

Saint-Etienne, 42055, France

Location

CHP Saint- Grégoire

Saint-Grégoire, 35760, France

Location

Hia Sainte Anne

Toulon, France

Location

Related Links

• Official web site of the sponsor

MeSH Terms

Interventions

apalutamide

Study Officials

• Gwenaelle GRAVIS, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 23, 2017
• Study Start: April 28, 2017
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

FR (13)