Summary
Bicalutamide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Prostate Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Prostate Cancer. ClinicalTrials.gov lists 8 registered trials linking Bicalutamide to Prostate Cancer: 1 is active or not yet recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03971110). The largest enrolment is 452 participants (NCT02454543). Registration activity spans 2001 to 2021. The literature layer holds 11 publications for this pair: 5 Cochrane reviews, 1 systematic review and 5 clinical trial publications. Publication years run from 2020 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 Prostate Cancer ranks 50 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: Low-grade (Gleason 6/Grade Group 1): active surveillance appropriate in 40-50% — many will never need treatment; high-grade: lethal without treatment within 5-10 years.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 73.5 (trials 23.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 5 completed, 2 other |
| Linked publications | 11 (5 Cochrane reviews, 5 clinical trial publications, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ACP3 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT03971110 | A Study of Neoadjuvant Hormone Therapy in Patient With Advanced Prostate Cancer Undergoing Radical Prostatectomy. 2021 | terminated | Phase 4 | 9 |
| NCT04563936 | Efficacy and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX® 2020 | completed | Phase 3 | 290 |
| NCT00349557 | Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer 2006 | completed | Phase 2 | 18 |
| NCT02678520 | Clinical Trial Comparing 3-D RT vs. IMRT in Post- Prostatectomy Prostate Cancer Patients 2015 | withdrawn | Phase 2 | — |
| NCT00943956 | Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer 2009 | completed | Phase 1 | 30 |
| NCT00026377 | SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer 2001 | completed | Phase 1 | 3 |
| NCT02454543 | Impact of Radical Prostatectomy as Primary Treatment in Patients With Prostate Cancer With Limited Bone Metastases 2015 | active, not recruiting | Not applicable | 452 |
| NCT02376296 | Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients 2015 | completed | Not applicable | 35 |
Published literature
- Clinical trial publication Phase II Randomized Study of MK-2206 and Bicalutamide in Prostate Cancer Patients With Rising PSA After Primary Therapy (ECOG-ACRIN E2809)Ferrari AC, Chen YH, Rodríguez R et al. · The Prostate · 2026 · PMID 41609418
- Clinical trial publication Long-Term Results of NRG/RTOG 9601, a Randomized Trial of Radiation With or Without Antiandrogens in Patients Receiving Salvage Prostate Bed Radiation Therapy PostprostatectomyLukka HR, Pugh SL, Shipley WU et al. · International journal of radiation oncology, biology, physics · 2025 · PMID 40752653
- Clinical trial publication Prognostic Impact of Lymph Node Yield in a Phase III Clinical Trial (NRG/RTOG 9601) of Prostate Cancer Patients Treated With Salvage Radiation Following ProstatectomyChan E, Pugh SL, Simko JP et al. · The Prostate · 2025 · PMID 40686005
- Clinical trial publication Correlation of Body Mass Index with Overall Survival Among Patients with Metastatic Hormone-sensitive Prostate Cancer: Analysis of Patient-level Data from SWOG-1216Swami U, Jo Y, Narang A et al. · European urology oncology · 2025 · PMID 39521639
- Clinical trial publication Patient-reported outcomes of rezvilutamide versus bicalutamide in combination with androgen deprivation therapy in high-volume metastatic hormone-sensitive prostate cancer patients (CHART): a randomized, phase 3 studyWang H, Jiang S, Luo H et al. · Signal transduction and targeted therapy · 2024 · PMID 39690158
- Cochrane review Oral chemotherapeutic agents in metastatic hormone-sensitive prostate cancer: A network meta-analysis of randomized controlled trialsLee YS, Kim SH, Tae JH et al. · Prostate international · 2023 · PMID 37745904
- Cochrane review The efficacy and adverse events of conventional and second-generation androgen receptor inhibitors for castration-resistant prostate cancer: A network meta-analysisZhang X, Zhang G, Wang J et al. · Frontiers in endocrinology · 2023 · PMID 36843606
- Cochrane review Synergistic effects of natural products in combination with anticancer agents in prostate cancer: A scoping reviewCheon C, Ko SG · Frontiers in pharmacology · 2022 · PMID 36172195
- Systematic review Cognition and depression effects of androgen receptor axis-targeted drugs in men with prostate cancer: A systematic reviewBatra A, Marchioni M, Hashmi AZ et al. · Journal of geriatric oncology · 2021 · PMID 33234494
- Cochrane review Evaluation of Fall and Fracture Risk Among Men With Prostate Cancer Treated With Androgen Receptor Inhibitors: A Systematic Review and Meta-analysisMyint ZW, Momo HD, Otto DE et al. · JAMA network open · 2020 · PMID 33201234
- Cochrane review Systemic Management for Nonmetastatic Castration-resistant Prostate Cancer: A Systematic Review and Network Meta-AnalysisLiu Z, Zhang T, Ma Z et al. · American journal of clinical oncology · 2020 · PMID 31972568
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 ACP3. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Bicalutamide approved for Prostate Cancer?
Bicalutamide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Prostate Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Prostate Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Bicalutamide in clinical trials for Prostate Cancer?
ClinicalTrials.gov lists 8 registered trials linking Bicalutamide to Prostate Cancer: 1 is active or not yet recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03971110). The largest enrolment is 452 participants (NCT02454543). Registration activity spans 2001 to 2021.
What does the evidence show for Bicalutamide in Prostate Cancer?
Bicalutamide has both completed registered trials and synthesis-level publications linked to Prostate 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 ACP3. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.