A phase II study in low risk prostate cancer patients to compare active surveillance with versus without an antiandrogenic treatment.

Phase 1

Conditions: ow risk localized prostate cancer
MedDRA version: 20.0Level: LLTClassification code 10007113Term: Cancer of prostateSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-001266-29-FR

Lead Sponsor: Institut Paoli Calmettes

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 206

Inclusion Criteria

Potential subjects must satisfy all the following 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 defined by:
- Clinical Stage: T1c or T2a
- Sampled biopsy with less of 3 positive cores and tumor length < 3 mm per core (< 7mm 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:
a)Hemoglobin =9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
b)Platelet count =100,000 x 109/µL independent of transfusion and/or growth factors within 3 months prior to randomization
c)Serum albumin =3.0 g/dL
d)Serum creatinine <2.0 × upper limit of normal (ULN)
e)Serum potassium =3.5 mmol/L
f)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)
g)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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 154
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52

Exclusion Criteria

Potential subjects who meet any of the following criteria cannot be included in the study:
1-Prior treatment for prostate cancer including a 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