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. 2020 Dec 3;2020(12):CD013020. doi: 10.1002/14651858.CD013020.pub2

Pan 2014.

Study characteristics
Methods Recruitment period:
  • June 2008 to April 2010


Outcomes:
  • overall survival, SREs, disease progression, pain response, adverse events


Pain assessment tool:
  • 10‐centimeter VAS


Randomization:
  • intervention vs control

Participants Eligibility criteria:
  • men with histologically confirmed castration‐resistant prostate cancer (defined by 3 sequential rises in serum PSA level with castrate levels of serum testosterone (50 ng/dL) or increase in cancer‐related pain or new metastatic lesions on hormonal therapy, or a combination of these)

  • age > 18 years

  • ECOG performance status ≤ 2

  • life expectancy > 3 months

  • evidence of bone metastases by 2 radiographic methods


Exclusion criteria:
  • previous use of bisphosphonates within 1 year prior to study enrollment

  • previous chemotherapy

  • radiation therapy or surgery to metastatic bone lesions within 1 month at time of study enrollment

  • brain metastasis

  • psychological symptoms

  • significant renal, hepatic, or non‐malignant‐related disease


Participants randomized:
  • 105 randomized, 53 intervention, 52 control


Mean age:
  • intervention: < 71 years: 34%, > 71 years: 66%

  • control: < 71 years: 38.5%, > 71 years: 61.5%


Country of participants:
  • China

Interventions Previous interventions:
  • not reported


Interventions during study period:
  • intervention: zoledronic acid 4 mg IV every 3 weeks, 75 mg/m2 docetaxel IV on day 1 of a 21‐day cycle, prednisone 10 mg daily, supplemental calcium 500 mg orally daily, supplemental vitamin D 400 IU orally daily

  • control: saline (placebo) IV every 3 weeks, 75 mg/m2 docetaxel IV on day 1 of a 21‐day cycle, prednisone 10 mg daily, supplemental calcium 500 mg orally daily, supplemental vitamin D 400 IU orally daily

Outcomes Reported and analyzed in this review:
  • overall survival

  • SREs

  • pain response

  • adverse events

Funding sources Funding sources:
  • Wenzhou science bureau project

Declarations of interest Conflicts of interest:
  • none of the authors had a conflict of interest

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient report on sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient information on allocation concealment
Blinding of participants and personnel (performance bias)
Blinding of participants Unclear risk Placebo‐controlled trial, no further information on blinding
Blinding of participants and personnel (performance bias)
Blinding of personnel Unclear risk No information on blinding of participants and personnel
Blinding of outcome assessment (detection bias)
Outcomes subjective to participants Unclear risk No information on blinding of participants and personnel
Blinding of outcome assessment (detection bias)
Outcomes subjective to outcome assessors Unclear risk Insufficient reporting on blinding of outcome assessor
Blinding of outcome assessment (detection bias)
Objective outcomes Low risk No known reason for bias
Incomplete outcome data (attrition bias)
Time‐to‐event data Low risk "All patients were evaluated for the efficacy and safety every one treatment cycle until death or severe toxicity"
Incomplete outcome data (attrition bias)
Patient‐reported outcomes (other than safety data) Low risk No participants lost to follow‐up.
All participants were included in the ITT analysis.
Incomplete outcome data (attrition bias)
Safety data Low risk "All patients were evaluated for the efficacy and safety every one treatment cycle until death or severe toxicity"
Incomplete outcome data (attrition bias)
Other outcomes Unclear risk No participants lost to follow‐up.
All participants were included in the ITT analysis.
Selective reporting (reporting bias) Unclear risk No study protocol available.
Other bias Low risk None identified