Disease × agent evidence record

Bicalutamide for Cancer: evidence, trials and status

Bicalutamide has both completed registered trials and synthesis-level publications linked to Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit.

8 registered trials 0 recruiting 14 publications Evidence tier A · Strong Score 74.0
Research Tracker › Pairs › Cancer › Bicalutamide
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Bicalutamide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Cancer. ClinicalTrials.gov lists 8 registered trials linking Bicalutamide to Cancer: 2 are active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT04563936). The largest enrolment is 452 participants (NCT02454543). Registration activity spans 2001 to 2020. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2015 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.

The RepurpOS disease-intelligence file for Cancer ranks 1226 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous regression is rare (<0.5% of cases); 5-year survival without treatment: <5% for advanced NSCLC; ~20% for stage I-II with surgery.

Open in Repurposing ExplorerCancer hubChEMBLOpen Targets

Evidence table

Evidence tierA · Strong
Evidence score74.0 (trials 24.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 0 recruiting, 2 active / not yet recruiting, 5 completed, 1 other
Linked publications14 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 2 systematic reviews)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesOpen Targets, ChEMBL
Linked via biomarker / targetABL1
How the evidence score is calculated
  • Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
  • Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
  • The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
  • Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
  • The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.

Registered clinical trials

NCT IDTitleStatusPhaseEnrolment
NCT04563936Efficacy and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX®
2020
completedPhase 3290
NCT00349557Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer
2006
completedPhase 218
NCT02678520Clinical Trial Comparing 3-D RT vs. IMRT in Post- Prostatectomy Prostate Cancer Patients
2015
withdrawnPhase 2—
NCT00943956Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer
2009
completedPhase 130
NCT00026377SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
2001
completedPhase 13
NCT02605486Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)
2015
active, not recruitingPHASE1, PHASE246
NCT02454543Impact of Radical Prostatectomy as Primary Treatment in Patients With Prostate Cancer With Limited Bone Metastases
2015
active, not recruitingNot applicable452
NCT02376296Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients
2015
completedNot applicable35

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Published literature

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Mechanism and notes

No mechanism of action is recorded for this pair in the source databases.

OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ABL1. The tier describes how well the drug-disease link is documented, not how well the drug works.

Frequently asked questions

Is Bicalutamide approved for Cancer?

Bicalutamide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.

Is Bicalutamide in clinical trials for Cancer?

ClinicalTrials.gov lists 8 registered trials linking Bicalutamide to Cancer: 2 are active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT04563936). The largest enrolment is 452 participants (NCT02454543). Registration activity spans 2001 to 2020.

What does the evidence show for Bicalutamide in Cancer?

Bicalutamide has both completed registered trials and synthesis-level publications linked to Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ABL1. The tier describes how well the drug-disease link is documented, not how well the drug works.

Cite this page

Open Source Medicine Foundation. Bicalutamide for Cancer: evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/cancer/bicalutamide.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.