# STOpCaP: docetaxel or bisphosphonates added to standard of care in hormone-sensitive prostate cancer, a systematic review and meta-analysis

Source: https://onco.cc/key-papers/paper-vale-stopcap-docetaxel-bisphosphonates-lancet-oncol-2016/  
OnCo record `paper-vale-stopcap-docetaxel-bisphosphonates-lancet-oncol-2016` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Three trials of chemotherapy at the start of hormone therapy had reported, two positive and one negative. Pooling them showed the treatment does work in metastatic disease, improving four-year survival by about nine percent, and that zoledronic acid does not.

## Summary

Claire Vale, Jayne Tierney and the STOpCaP steering group ran a framework for adaptive meta-analysis over every randomised trial of docetaxel or bisphosphonates added to standard care in high-risk localised or metastatic hormone-sensitive prostate cancer, taking hazard ratios from publications, presentations and directly from investigators.

This is the paper that settled the contradiction between GETUG-AFU 15, CHAARTED and STAMPEDE, and it is worth reading for its method as much as for its result: an adaptive meta-analysis is designed to be run while trials are still reporting, rather than years afterwards. It also did something rarer, which is to close a question in the negative: it found no evidence that zoledronic acid improves survival in either metastatic or non-metastatic disease.

## Fields

- Kind: Key paper
- Last checked: 2026-09-25
- Also known as: STOpCaP; Vale 2016 docetaxel meta-analysis; adaptive meta-analysis prostate docetaxel
- Tags: prostate-evidence
- Journal: The Lancet Oncology
- Year: 2016
- DOI: 10.1016/s1470-2045(15)00489-1
- Authors: Vale CL, Burdett S, Rydzewska LHM, et al.
- Findings: In metastatic disease, docetaxel added to standard of care improved survival: hazard ratio 0.77 (95 percent confidence interval 0.68 to 0.87; p less than 0.0001), an absolute improvement in four-year survival of 9 percent (5 to 14), from three trials covering 2,992 of 3,206 randomised men.; Failure-free survival hazard ratio 0.64 (0.58 to 0.70; p less than 0.0001), a reduction in absolute four-year failure rates of 16 percent (12 to 19).; In locally advanced (M0) disease, no evidence of a survival benefit from docetaxel: hazard ratio 0.87 (0.69 to 1.09; p equals 0.218) from three trials covering 2,121 of 3,978 men, although failure-free survival improved (0.70, 0.61 to 0.81).; No evidence that zoledronic acid improves survival in metastatic disease (hazard ratio 0.94, 0.83 to 1.07; p equals 0.323) or in M0 disease (0.98, 0.82 to 1.16; p equals 0.782).; The bisphosphonate survival signal in metastatic disease (0.88, 0.79 to 0.98; p equals 0.025) was influenced by the positive result of one trial of sodium clodronate.
- What it means: The answer to a question three individual trials could not answer on their own, and the reason docetaxel with androgen deprivation became standard for metastatic hormone-sensitive disease. It also stopped a widely used bone drug being credited with a survival effect it does not have.
- Caveats: An aggregate-data meta-analysis, not individual patient data, so subgroup effects such as disease volume cannot be examined directly.; The M0 result rests on fewer than two thirds of the randomised men, because survival data were not available from every trial.; Standard of care has since changed: the comparator arms received androgen deprivation alone, while today they would usually receive an androgen receptor pathway inhibitor as well.

## Sources

- Lancet Oncol 2016: https://doi.org/10.1016/s1470-2045(15)00489-1
- PubMed: https://pubmed.ncbi.nlm.nih.gov/26718929/

## Connected records

- key papers: [Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial](https://onco.cc/key-papers/paper-stampede-lancet-2016/), [CHAARTED: chemohormonal therapy in metastatic hormone-sensitive prostate cancer](https://onco.cc/key-papers/paper-chaarted-nejm-2015/), [GETUG-AFU 15: androgen deprivation alone or with docetaxel in non-castrate metastatic prostate cancer](https://onco.cc/key-papers/paper-gravis-getug-afu-15-docetaxel-lancet-oncol-2013/), [STAMPEDE: adding abiraterone to hormone therapy at diagnosis of advanced prostate cancer](https://onco.cc/key-papers/paper-stampede-abiraterone-nejm-2017/)
- roadmaps: [Prostate cancer roadmap: from Huggins and the discovery that a cancer can depend on a hormone, through the PSA epidemic and what it cost, the androgen receptor drugs, the DNA repair subset and PSMA, to a 2032 registry watch](https://onco.cc/roadmaps/prostate-roadmap/)
- cancers: [Metastatic hormone-sensitive prostate cancer](https://onco.cc/cancers/prostate-mhspc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- fronts: [Chemotherapy](https://onco.cc/fronts/chemotherapy/), [Hormonal Therapy](https://onco.cc/fronts/hormonal/)
- drugs: [Docetaxel](https://onco.cc/drugs/docetaxel/), [Zoledronic acid](https://onco.cc/drugs/zoledronic-acid/)
- terms: [Androgen deprivation therapy (ADT)](https://onco.cc/terms/adt/), [Bone metastases and skeletal-related events](https://onco.cc/terms/bone-metastases/), [Hazard ratio (HR)](https://onco.cc/terms/hazard-ratio/)
- people: [Christopher J. Sweeney](https://onco.cc/people/christopher-sweeney/), [Karim Fizazi](https://onco.cc/people/karim-fizazi/), [Nicholas James](https://onco.cc/people/nicholas-james/)
- bottlenecks: [Failures are hidden](https://onco.cc/bottlenecks/b-negative-results/), [Knowledge reaches practice too slowly](https://onco.cc/bottlenecks/b-knowledge-diffusion/), [Trial design, endpoints and cost](https://onco.cc/bottlenecks/b-trial-design/)
- journals: [The Lancet Oncology](https://onco.cc/journals/lancet-oncology/)

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