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NCT03358563
Pilot Trial of Chemohormonal Therapy Followed by Prostatectomy in High Risk Prostate Cancer
EARLY_PHASE1 trial testing Docetaxel in Prostate Cancer in 30 participants. Completed in 2 September 2022.
10 August 2021
Quick facts
| Lead sponsor | University of Wisconsin, Madison |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 17 January 2018 |
| Primary completion | 10 August 2021 |
| Estimated completion | 2 September 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Docetaxel (Docetaxel) — full drug profile →
- Degarelix (degarelix) — full drug profile →
- Bicalutamide (bicalutamide) — full drug profile →
- Ferumoxytol-enhanced MRI imaging
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
University of Wisconsin, Madison
Who can join
18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a pilot multimodality treatment approach trial with androgen deprivation therapy in combination with docetaxel chemotherapy followed by radical prostatectomy in patients with newly diagnosed high-risk and oligometastatic prostate cancer. This study aims to evaluate the rates of complete pathologic response (pCR) at the time of prostatectomy as well as PSA response, time to PSA recurrence and safety and toxicity of the combination. This study will be heavily embedded with biomarker analyses of the tumor and tumor cells in circulation as well in the bone marrow before and after treatment and will also include imaging analyses using a novel positron emission tomography (PET) imaging technology.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Oligometastatic prostate cancer: Reality or figment of imagination?
Foster CC, Weichselbaum RR, Pitroda SP. · · 2019 · cited 67× · PMID 30521067 · DOI 10.1002/cncr.31860 -
Androgen deprivation therapy in nonmetastatic prostate cancer patients: Indications, treatment effects, and new predictive biomarkers.
Fang D, Zhou L. · · 2019 · cited 21× · PMID 30729683 · DOI 10.1111/ajco.13108 -
Pharmacogenomic Biomarkers in Docetaxel Treatment of Prostate Cancer: From Discovery to Implementation.
Varnai R, Koskinen LM, Mäntylä LE, Szabo I, et al · · 2019 · cited 17× · PMID 31398933 · DOI 10.3390/genes10080599 -
Neoadjuvant Therapy in High-Risk Prostate Cancer.
Ashrafi AN, Yip W, Aron M. · · 2020 · cited 11× · PMID 33376260 · DOI 10.4103/iju.iju_115_20 -
Mri-based cancer lesion analysis with 3d printed patient specific prostate cutting guides.
Rutkowski DR, Wells SA, Johnson B, Huang W, et al · · 2019 · cited 4× · PMID 31511828
Verify or expand the search:
- PubMed search for NCT03358563
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
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- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
Other University of Wisconsin, Madison trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03358563 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Wisconsin, Madison
- Last refreshed: 3 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03358563.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing