A Phase 3 interventional study of abiraterone acetate and radiotherapy in Metastatic Prostate Cancer, sponsored by UNICANCER. Active, not recruiting at 77 sites in 7 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by UNICANCER · Phase 3, Interventional, and Treatment
This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.
Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.
The randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.
The randomization will be stratified (by minimization) according to:
CRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (\<0.50 ng/mL).
When the CRPC stage is reached, castration (either LHRH agonist or LHRH antagonist) will be maintained in all patients.
Investigators will be free to manage patients reaching CRPC at their discretion (using for example docetaxel, zoledronic acid, denosumab, sipuleucel-T, radium-223, cabazitaxel, etc) according to local uses and guidelines.
Abiraterone may be used in arm A and C if abiraterone has become the standard treatment for CRPC when this stage is reached.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 1,173 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →UNICANCER is the lead sponsor of 215 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Metastatic disease documented by a positive bone scan (any technique) or CT scan or an MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they have either:
o At least one extra-pelvic lymph node ≥ 2 cm or extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph node ≥ 2 cm
Hematology values:
Biochemistry values:
Liver function:
Patients willing and clinically fit to receive Docetaxel which is defined by the following :
Exclusion Criteria:
Patients with impaired vision should undergo a prompt and complete ophthalmologic examination.
Patients with Cystoid Macular Oedema cannot be included due to a potential risk of deterioration associated with docetaxel.
androgen deprivation therapy + docetaxel
Other: Androgen Deprivation Therapy · Drug: Docetaxel
androgen deprivation therapy + docetaxel + abiraterone acetate + prednisone
Drug: abiraterone acetate · Other: Androgen Deprivation Therapy · Drug: Docetaxel
Arm A + radiotherapy
Radiation: radiotherapy · Other: Androgen Deprivation Therapy · Drug: Docetaxel
Arm B + radiotherapy
Drug: abiraterone acetate · Radiation: radiotherapy · Other: Androgen Deprivation Therapy · Drug: Docetaxel
abiraterone 1000mg/day (4 tablets of 250 mg (PO) per day) + prednisone 5mg bid
Also known as: Zytiga
74 Gy in 37 fractions 3D-Conformal RT or Intensity Modulated RT (IMRT)
The ADT must consist in either LHRH agonist, LHRH antagonist or orchiectomy
6 cycles at 75mg/m²/cycle, one cycle every 3 weeks
Survival
Overall and radiographic progression-free survival in patients with metastatic hormone-naïve prostate cancer treated by androgen deprivation therapy and docetaxel
Time frame: 7.5 years after the first inclusion
Survival
Overall and radiographic progression-free survival in hormone-naïve prostate cancer patients with low metastatic burden whatever the standard of care received
Time frame: 9.5 years after the first inclusion
Castration resistance-free survival (CRFS)
Time frame: 9.5 years after the first inclusion
Serious Genitourinary event-free survival (S-GU-EFS)
Time frame: 9.5 years after the first inclusion
Prostate cancer specific survival
Time frame: 9.5 years after the first inclusion
Time to next skeletal-related event
Time frame: 9.5 years after the first inclusion
PSA response rate
Time frame: 9.5 years after the first inclusion
Prospective correlative study of PSA response/progression at 8 months after initation of ADT
Time frame: 9.5 years after the first inclusion
Time to pain progression
will be evaluated by questionnaires
Time frame: 9.5 years after the first inclusion
Time to chemotherapy for CRPC
Time frame: 9.5 years after the first inclusion
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Time frame: At baseline, 6 months, 18 months, and at the end of treatment (up to 9.5 years)
Functional Assessment of Cancer Therapy - Prostate (FACT-P)
The FACT-P is a self-assessment questionnaire to estimate the health-related quality of life in men with prostate cancer. This questionnaire, composed of 39 items consists of four subscales: Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), Functional Well-Being (7 items), and prostate cancer subscale (12 items). Subscales are rated on 5-point Likert-type scale (from 0 = "Not at all" to 4 = "Very much"). For all subscales, a higher score represents better quality of life.
Time frame: At baseline, 6 months, 12 months, 18 months, and at the end of treatment (up to 9.5 years)
Toxicity (with a specific focus on the use of long-term low-dose steroids)
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Time frame: Throughout study completion, up to 9.5 years
Changes in bone mineral density
X-rays are used to measure how many grams of calcium and other bone minerals are packed into a segment of bone
Time frame: At baseline, 6 months, 12 months, and 24 months
Correlation of biomarkers with outcome
Correlation of biomarkers with outcome, including the prognostic and predictive value on OS, rPFS and CRFS of a neuro-endocrine differentiation of the prostate cancer in the pathological specimen.
Time frame: 9.5 years after the first inclusion
Plan to share: No — Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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