Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy (CARLHA-2)

  • STATUS
    Recruiting
  • End date
    Dec 28, 2033
  • participants needed
    490
  • sponsor
    UNICANCER
Updated on 25 February 2022
prostatectomy
gonadotropin
androgens
metastasis
antiandrogen therapy
androgen suppression
luteinizing hormone-releasing hormone agonist
luteinizing hormone
apalutamide
adenocarcinoma
adenocarcinoma of prostate
gonadorelin

Summary

This is a multicenter, randomized, open label, phase III study comparing the efficacy and safety of apatulamide combined with concomitant prostate-bed salvage radiotherapy (SRT) and androgen deprivation therapy (ADT) versus concomitant prostate-bed SRT and ADT in high-risk postprostatectomy biochemically relapsed prostate cancer patients.

Description

The purpose of the CARLHA-2 study is to determine if the combination of apalutamide with 6 months of LHRH agonists and radiotherapy results in an improvement of progression-free survival (PFS) in comparison to the combination of 6 months of LHRH agonists with radiotherapy in high-risk postprostatectomy biochemically relapsed prostate cancer patients.

Radical prostatectomy must have been done at least 6 months before inclusion and is not part of this study.

Patients after radical prostatectomy and biochemical relapse will be randomized in a 1:1 ratio to receive either 6 months of LHRH agonists + SRT or 6 months of LHRH agonists + SRT + 6 months of apalutamide.

The stratification variables include Gleason score, prostate-specific antigen (PSA), negative resection margins, extension to seminal vesicle(s), and PSA doubling time.

Details
Condition Prostate Cancer
Treatment Apalutamide, Salvage radiotherapy (SRT), Luteinising Hormone Releasing Hormone agonist (LHRHa)
Clinical Study IdentifierNCT04181203
SponsorUNICANCER
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must have signed a written informed consent form prior to any trial specific procedures
Age 18 years old and 80 years old
Histologically confirmed diagnosis of prostate adenocarcinoma treated primarily with radical prostatectomy
Pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx])
Tumor stage pT2, pT3 or pT4 _(_ only in case of bladder neck involvement)
Patients should have no clinical and radiological signs (18FCH-PET CT-scan or 68Ga-PSMA-PET CT-scan) of metastatic disease. Patients with a local relapse detected on PET CT-scan can be randomized
Eastern Cooperative Oncology Group (ECOG) performance status 1
PSA 0.5 ng/mL after radical prostatectomy (dosage performed within 3 months after surgery)
PSA 0.2 ng/mL and 2 ng/mL at the time of randomization with an elevation of PSA over three consecutive assays
At least 3 months between radical prostatectomy and inclusion
High-risk features as defined by at least one of these characteristics: PSA at relapse >0.5 ng/mL or Gleason score >7 or tumor stage pT3b or resection margins R0 or PSA doubling time 6 months
Adequate renal function: serum creatinine <1.5 x upper limit of normal (ULN) or a calculated corrected creatinine clearance 60 mL/min according to the Cockcroft-Gault formula, creatinemia <2 ULN
Adequate hepatic function: total bilirubin 1.5 x ULN (unless documented Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 x ULN
Patients with QTc prolongation <500 ms, inclusion should considered after close benefit/risk assessment and cardiologist advice
Patients with female partners of reproductive potential should agree to use effective contraceptive method during treatment period and for 3 months after the last dose of apalutamide or for 6 months after the last fraction of radiotherapy
Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
Patients must be affiliated to the Social Security System

Exclusion Criteria

Histologically proven lymph nodes involvement at initial lymphadenectomy: pN1, pN2, pN3
Previous treatment with hormone therapy for prostate cancer
Histology other than adenocarcinoma
Surgical or chemical castration
Other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been cured for at least 5 years
Previous pelvic radiotherapy
History of Inflammatory bowel disease or any malabsorption syndrome or conditions that would interfere with enteral absorption
Uncontrolled hypertension (defined as systolic blood pressure (BP) 140 mmHg or diastolic BP 90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
Clinically significant history of liver disease consistent with Child-Pugh class B or C
History of seizure or condition that may pre-dispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness 1 year prior to randomization; brain arteriovenous malformation or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
Severe or 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
Certain risk factors for abnormal heart rhythms/QT prolongation: torsade de pointes ventricular arrhythmias (e.g, heart failure, hypokalemia, or a family history of a long QT syndrome), a QT or corrected QT (QTc) interval >500 ms at baseline
Medications known to prolong QTc
Known hypersensitivity to apalutamide or to any of its components
Galactosemia, Glucose-galactose malabsorption or lactase deficiency
Inability or willingness to swallow oral medication
Individual deprived of liberty or placed under the authority of a tutor
Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within the 30 days before inclusion
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