TriangleNCT00417079 · CITED IN SOURCE DOCUMENTS
XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2011-03-10
This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Overall Survival
Time to Progression Free Survival (PFS)
Overall Tumor Response
Time to Tumor Progression
Time to Prostatic Specific Antigen (PSA) Progression
PSA (Prostate-Specific Antigen) Response
Time to Pain Progression
Pain Response
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria 1. Histologically or cytologically confirmed adenocarcinoma of the prostate that is refractory to hormone therapy and previously treated with a Taxotere®-containing regimen. 2. Documented progression of disease (demonstrating at least one visceral or soft tissue metastatic lesion, including a new lesion). Patients with non-measurable disease must have documented rising prostate-specific antigen (PSA) levels or appearance of new lesion. 3. Surgical or hormone-induced castration 4. Life expectancy \> 2 months 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 Exclusion criteria 1. Previous treatment with mitoxantrone 2. Previous treatment with \<225 mg/m\^2 cumulative dose of Taxotere (or docetaxel) 3. Prior radiotherapy to ≥ 40% of bone marrow 4. Surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment in the study 5. Other prior malignancy, except for adequately treated superficial basal cell skin cancer, or any other cancer from which the patient has been disease-free for less than 5 years 6. Known brain or leptomeningeal involvement 7. Other concurrent serious illness or medical conditions 8. Inadequate organ function evidenced by unacceptable laboratory results The investigator will evaluate whether there are other reasons why a patient may not participate.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- MALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Mitoxantrone + Prednisone
- intervention Names
- Drug: mitoxantrone
- Drug: prednisone
- label
- Mitoxantrone + Prednisone
- type
- ACTIVE_COMPARATOR
- description
- Cabazitaxel + Prednisone
- intervention Names
- Drug: cabazitaxel (XRP6258) (RPR116258)
- Drug: prednisone
- label
- Cabazitaxel + Prednisone
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Cabazitaxel + Prednisone
- description
- 25 mg/m\^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle
- name
- cabazitaxel (XRP6258) (RPR116258)
- other Names
- Jevtana
- type
- DRUG
- arm Group Labels
- Mitoxantrone + Prednisone
- description
- 12 mg/m\^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle
- name
- mitoxantrone
- type
- DRUG
- arm Group Labels
- Cabazitaxel + Prednisone
- Mitoxantrone + Prednisone
- description
- 10 mg daily administered by oral route
- name
- prednisone
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 755
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, the survival time was censored at the last date patient was known to be alive or at the cut-off date, whichever had come first.
- measure
- Overall Survival
- time Frame
- From the date of randomization up to 104 weeks (study cut-off)
- secondary Outcomes
- description
- Progression free survival was defined as a composite endpoint evaluated from the date of randomization to the date of tumor progression, PSA progression, pain progression, or death due to any cause, whichever occurred first
- measure
- Time to Progression Free Survival (PFS)
- time Frame
- From the date of randomization up to 104 weeks (study cut-off)
- description
- Tumor Overall Response Rate (ORR) (only in patients with measurable disease): Objective responses (Complete Response and Partial Response) for measurable disease as assessed by investigators according to RECIST criteria. Complete Response (CR) is defined as: Disappearance of all target lesions. Partial Response (PR) is defined as: At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference baseline sum LD. Confirmation of objective responses will be performed by repeat tumor imaging (CT scans, MRI, bone scans) after the first documentation of response.
- measure
- Overall Tumor Response
- time Frame
- From the date of randomization up to 104 weeks (study cut-off)
- description
- Time to tumor progression is defined as the number of months from randomization until evidence of progressive disease (RECIST)
- measure
- Time to Tumor Progression
- time Frame
- From the date of randomization up to 104 weeks (study cut-off)
- description
- In PSA non-responders, progression will be defined as a 25% increase over nadir and increase in the absolute value PSA level by at least 5 ng/ml and confirmed by a second value at least 4 weeks later. In PSA responders and in patients not evaluable for PSA response at baseline, progression will be defined as a ≥50% increase over nadir, provided that the increase is a minimum of 5 ng/ml and confirmed by a second value at least 1 week later.
- measure
- Time to Prostatic Specific Antigen (PSA) Progression
- time Frame
- at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off)
- description
- PSA response was defined as a ≥ 50% reduction in serum PSA, determined only for patients with a serum PSA ≥ 20ng/mL at baseline, confirmed by a repeat PSA ≥ 3 weeks later.
- measure
- PSA (Prostate-Specific Antigen) Response
- time Frame
- from baseline up to 104 weeks (study cut-off)
- description
- Pain Progression is defined as an increase of ≥1 point in the median Personal Pain Intensity (PPI) from its nadir noted on 2 consecutive 3-week-apart visits or ≥25 % increase in the mean analgesic score compared with the baseline score \& noted on 2 consecutive 3-week-apart visits or requirement for local palliative radiotherapy. Evaluation of the PPI \& analgesic scores are based on the short-form McGill Pain Questionnaire which consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none (best) 1=mild 2=moderate 3=severe (worst) (TOTAL: 0=best 45=worst)
- measure
- Time to Pain Progression
- time Frame
- from baseline up to 104 weeks (study cut-off)
- description
- Pain Response was defined as a two-point or greater reduction from baseline median Present Pain Intensity (PPI) score without an increased Analgesic Score (AS) or a decrease of ≥50% in the AS without an increase in the PPI score, maintained for at least 3 weeks.
- measure
- Pain Response
- time Frame
- from baseline up to 104 weeks (study cut-off)
Full study description
- brief Summary
- This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.
Source references
- references
- citation
- Lorente D, Mateo J, Templeton AJ, Zafeiriou Z, Bianchini D, Ferraldeschi R, Bahl A, Shen L, Su Z, Sartor O, de Bono JS. Baseline neutrophil-lymphocyte ratio (NLR) is associated with survival and response to treatment with second-line chemotherapy for advanced prostate cancer independent of baseline steroid use. Ann Oncol. 2015 Apr;26(4):750-755. doi: 10.1093/annonc/mdu587. Epub 2014 Dec 23.
- pmid
- 25538172
- type
- DERIVED
- citation
- Bahl A, Oudard S, Tombal B, Ozguroglu M, Hansen S, Kocak I, Gravis G, Devin J, Shen L, de Bono JS, Sartor AO; TROPIC Investigators. Impact of cabazitaxel on 2-year survival and palliation of tumour-related pain in men with metastatic castration-resistant prostate cancer treated in the TROPIC trial. Ann Oncol. 2013 Sep;24(9):2402-8. doi: 10.1093/annonc/mdt194. Epub 2013 May 30.
- pmid
- 23723295
- type
- DERIVED
- citation
- Pouessel D, Oudard S, Gravis G, Priou F, Shen L, Culine S. [Cabazitaxel for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: the TROPIC study in France]. Bull Cancer. 2012 Jul-Aug;99(7-8):731-41. doi: 10.1684/bdc.2012.1608. French.
- pmid
- 22743148
- type
- DERIVED
- citation
- de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.
- pmid
- 20888992
- type
- DERIVED
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- , multi-center study in patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen (TROPIC, NCT00417079). A total of 755 patients were randomized to receive either JEVTANA 25 mg/m 2 intravenously every 3 weeks for a maximum of 10 cycles with prednisone 10 mg oral
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- during or after treatment with docetaxel, cabazitaxel was shown to improve survival compared with mitoxantrone in a randomized trial (<a href="/clinicaltrials/NCT00417079">NCT00417079</a>).[<a href="#cit/section_8.65">65</a>] In this trial, 755 such men were treated with prednisone (10 mg PO qd) and randomly assigned to receive
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- ter treatment with docetaxel, cabazitaxel was shown to improve survival compared with mitoxantrone in a randomized trial (<a href="/clinicaltrials/NCT00417079">NCT00417079</a>).[<a href="#cit/section_8.65">65</a>] In this trial, 755 such men were treated with prednisone (10 mg PO qd) and randomly assigned to receive either cabaz
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- Updated: May 14, 2025
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- May 14, 2025
Preserved source evidence · Not medical advice