A randomized, open label, Phase IIB trial of Optimal Sequencing of Treatment Options for Poor Risk Metastasized Castration Resistant Prostate Cancer Previously Treated with Docetaxel (OSTRICh trial)
- Conditions
- metastasized castration resistantProstate cancer1003859710036958
- Registration Number
- NL-OMON55594
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Histological diagnosis of prostate adenocarcinoma., 2. Able and willing
to provide informed consent and to comply with the study procedures, 3. Age
*18, 4. Evidence of bone, visceral and/or lymph node metastases on bone scan,
CT-scan or MRI., 5. Must have received at least one prior regimen of docetaxel
treatment for at least 12 weeks (four courses) and no other prostate cancer
treatments between docetaxel and randomization, other than prednisone., 6.
Continued androgen deprivation therapy either by LHRH agonist/ antagonist or
orchiectomy., 7. Treatment with curative intent is not an option and patient
has an indication for systemic treatment as judged by the medical care
provider, 8. Evidence of progressive metastatic disease by PSA progression
(Prostate Cancer Working Group 3 (PCWG3) criteria: at least 2 rises at a
minimum of 1-week intervals. The first PSA value must be * 2 ng/ml) and/or
radiological progression as evaluated by chest, abdominal, or pelvic CT/MRI
scan and/or bone scan within 28 days of registration (see Appendix III), 9.
Poor prognosis disease as defined by any of the following:, a) The presence of
liver metastases AND/OR, b) Development of castration-resistance within 12
months of orchiectomy or commencement of LHRH antagonist/agonist for metastatic
disease AND/OR, c) Progressive disease during docetaxel treatment or <6
months after completion of docetaxel treatment, 10. WHO PS 0-2., 11. Serum
testosterone < 50 ng/dL (< 1.7 nmol/L) within 28 days before treatment
group allocation, 12. At least 21 days have passed since completing
radiotherapy (exception for a single fraction of * 800 cGy to a restricted
field or limited-field radiotherapy to non-marrow bearing area such as an
extremity or orbit: at least 7 days prior to randomization)., 13. At least 21
days have passed since major surgery. , 14. Neuropathy * grade 1 at the time of
registration. , 15. Has recovered from all therapy-related toxicity to * grade
2 (except alopecia, anemia and any signs or symptoms of androgen deprivation
therapy) at the time of registration., 16. Eligible for cabazitaxel,
abiraterone acetate or enzalutamide as per standard of care practices., 17. Men
treated with cabazitaxel should use effective contraception throughout
treatment and are recommended to continue this for up to 6 months after the
last dose of cabazitaxel. Due to potential exposure via seminal liquid, men
treated with cabazitaxel should prevent contact with the ejaculate by another
person throughout treatment. Men being treated with cabazitaxel are advised to
seek advice on conservation of sperm prior to treatment.
1. Histologic evidence of small cell/neuroendocrine prostate cancer, 2. Any
treatment other than prednisone between docetaxel and cabazitaxel/abiraterone
OR enzalutamide sequence , 3. Uncontrolled severe illness or medical condition
(including uncontrolled diabetes mellitus). , 4. History of severe
hypersensitivity reaction (* grade 3) to docetaxel, abiraterone or enzalutamide
(whichever applies)., 5. History of severe hypersensitivity reaction (* grade
3) to polysorbate 80 containing drugs., 6. Concurrent or planned treatment with
strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week
wash-out period is necessary for patients who are already on these
treatments)., 7. Patients who have a concurrent yellow fever vaccination
(several weeks before start of treatment) must be excluded., 8. Dementia,
altered mental status, or any psychiatric condition, if this is in conflict
with the study., 9. Unable to swallow a whole tablet or capsule, 10.
Contraindications to the use of corticosteroid treatment, 11. Symptomatic
peripheral neuropathy Grade *2 (National Cancer Institute Common Terminology
Criteria [NCI CTCAE] v.4.0). , 12. Prior malignancy active within the previous
3 years except for locally curable cancers that have been apparently cured and
needing no subsequent therapy., 13. Inadequate organ and bone marrow function
as evidenced by:, a. Hemoglobin <10.0 g/dL, b. Absolute neutrophil count
<1.5 x 109/L, c. Platelet count < 100 x 109/L, d. AST/ SGOT and/ or ALT/
SGPT > 1.5 x ULN, Total bilirubin >1 x ULN (except for patients with
documented Gilbert*s disease).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method