Informations générales (source: ClinicalTrials.gov)
Active Surveillance With or Without a 6 Months Apalutamide Treatment in Low Risk Prostate Cancer: A Phase II Randomized Multicenter Trial (PC-ARN)
Interventional
Phase 2
Institut Paoli-Calmettes (Voir sur ClinicalTrials)
avril 2017
avril 2022
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Tenon | Olivier CUSSENOT | Contact (sur clinicalTrials) | |||
| INSTITUT MUTUALISTE MONTSOURIS | Eric BARRET, Dr | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chu de Nice - Nice - France | Matthieu DURAND | Contact (sur clinicalTrials) | |||
| Chu Hotel Dieu - Nantes - France | Jérôme RIGAUD | Contact (sur clinicalTrials) | |||
| Hia Sainte Anne - Toulon - France | Pierre-Henri SAVOIE | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU Hopital Edouard Herriot - 69437 - Lyon - France | Marc COLOMBEL, Pr | Contact (sur clinicalTrials) | |||
| Chu Pontchaillou - Rennes - France | Sébastien VINCENDEAU | Contact (sur clinicalTrials) | |||
| Chu Saint Etienne - 42055 - Saint Etienne - France | Nicolas MOTTET-AUSELO, Dr | Contact (sur clinicalTrials) | |||
| Clinique Beau Soleil - 34070 - Montpellier - France | Xavier REBILLARD, Dr | Contact (sur clinicalTrials) | |||
| Clinique La Croix Du Sud - Quint-Fonsegrives - France | Guillaume PLOUSSARD | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - 13009 - Marseille - Bouches Du Rhône - France | Dominique GENRE, MD | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion Criteria:
1. Out-patient aged ≥ 18 years old
2. With life expectancy of more than 5 years
3. With ECOG performance status = 0 or 1
4. Having read, understood, signed and dated the informed consent,
5. 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
6. Clinical laboratory values at screening:
1. Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 3
months prior to randomization
2. Platelet count ≥100,000 x 109/µL independent of transfusion and/or growth
factors within 3 months prior to randomization
3. Serum albumin ≥3.0 g/dL
4. Serum creatinine <2.0 × upper limit of normal (ULN)
5. Serum potassium ≥3.5 mmol/L
6. 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)
7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN
7. 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.
8. 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.
9. Having accepted the principle of active surveillance
10. Who is willing to participate to the study for a minimum period of 36 months
11. Able to swallow the study drug and comply with study requirements
12. Patient affiliated to the national "Social Security" regimen or beneficiary of this
regimen.
1. Out-patient aged ≥ 18 years old
2. With life expectancy of more than 5 years
3. With ECOG performance status = 0 or 1
4. Having read, understood, signed and dated the informed consent,
5. 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
6. Clinical laboratory values at screening:
1. Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 3
months prior to randomization
2. Platelet count ≥100,000 x 109/µL independent of transfusion and/or growth
factors within 3 months prior to randomization
3. Serum albumin ≥3.0 g/dL
4. Serum creatinine <2.0 × upper limit of normal (ULN)
5. Serum potassium ≥3.5 mmol/L
6. 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)
7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN
7. 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.
8. 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.
9. Having accepted the principle of active surveillance
10. Who is willing to participate to the study for a minimum period of 36 months
11. Able to swallow the study drug and comply with study requirements
12. Patient affiliated to the national "Social Security" regimen or beneficiary of this
regimen.
1. Prior treatment for prostate cancer with surgery or radiotherapy or including
5-alpha reductase inhibitor (finasteride or dutasteride) and antiandrogen
2. Absolute neutrophil count < 1,500/μL,
3. 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)
4. 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
5. 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
6. 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.
7. Gastrointestinal disorder affecting absorption
8. Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis) or
other medical condition that would make prednisone/prednisolone (corticosteroid) use
contraindicated
9. Any other condition that, in the opinion of the Investigator, would impair the
patient's ability to comply with study procedures
10. Mental deficiency or any other reason that may hinder the understanding or the
strict application of the Protocol
11. Patient placed under judicial protection, tutorship, or curatorship
12. Patient unlikely to attend control visits
13. Patient currently enrolled in an investigational study or having participated to
another investigational study within the past 3 months