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NCT01163084
Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer
Phase 1, PHASE2 trial testing Goserelin Acetate in Prostate Adenocarcinoma in 10 participants. Terminated before completion.
1 June 2012
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 9 July 2010 |
| Primary completion | 1 June 2012 |
| Estimated completion | 1 June 2012 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Goserelin Acetate (GOSERELIN ACETATE) — full drug profile →
- Laboratory Biomarker Analysis — full drug profile →
- Leuprolide Acetate (leuprolide-acetate) — full drug profile →
- Vismodegib (vismodegib) — full drug profile →
Conditions studied
- Prostate Adenocarcinoma — all drugs for Prostate Adenocarcinoma →
- Stage IIA Prostate Cancer AJCC v7 — all drugs for Stage IIA Prostate Cancer AJCC v7 →
- Stage IIB Prostate Cancer AJCC v7 — all drugs for Stage IIB Prostate Cancer AJCC v7 →
Sponsor
National Cancer Institute (NCI)
Who can join
18 and older, male only, with Prostate Adenocarcinoma or Stage IIA Prostate Cancer AJCC v7. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: During on-study tests/visits that occur every 4 weeks for all participants until the follow up visit after radical prostatectomy, assessed up to 5 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Other adverse events (27 terms — click to expand)
| Reaction | System | Group A- GDC-0449 and Andr… | Group B- Androgren Ablatio… |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Hot flashes | Vascular disorders | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Cholesterol, high | Investigations | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Depression | Psychiatric disorders | — | — |
| Edema Limbs | Blood and lymphatic system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Hyperuricemia | Metabolism and nutrition disorders | — | — |
| hypotension | Vascular disorders | — | — |
| Pain | General disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Proteinuria | Renal and urinary disorders | — | — |
| Rash acneiform | Skin and subcutaneous tissue disorders | — | — |
| Rash pustular | Skin and subcutaneous tissue disorders | — | — |
| Spasticity | Nervous system disorders | — | — |
| Urinal frequency | Renal and urinary disorders | — | — |
| Watering eyes | Eye disorders | — | — |
| Dry Skin | Skin and subcutaneous tissue disorders | — | — |
Data from ClinicalTrials.gov NCT01163084 adverse events section.
Sponsor's own description
This randomized phase I/II trial studies giving leuprolide acetate or goserelin acetate together with or without vismodegib followed by surgery to see how well they work in treating patients with prostate cancer that has spread from where it started to nearby tissue or lymph nodes. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate or goserelin acetate, may lessen the amount of androgens made by the body. Vismodegib may slow the growth of tumor cells. Giving antihormone therapy together with vismodegib may be an effective treatment for prostate cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting Notch, Hedgehog, and Wnt pathways in cancer stem cells: clinical update.
Takebe N, Miele L, Harris PJ, Jeong W, et al · · 2015 · cited 1034× · PMID 25850553 · DOI 10.1038/nrclinonc.2015.61 -
Targeting the Sonic Hedgehog Signaling Pathway: Review of Smoothened and GLI Inhibitors.
Rimkus TK, Carpenter RL, Qasem S, Chan M, et al · · 2016 · cited 411× · PMID 26891329 · DOI 10.3390/cancers8020022 -
Molecular pathways: novel approaches for improved therapeutic targeting of Hedgehog signaling in cancer stem cells.
Justilien V, Fields AP. · · 2015 · cited 103× · PMID 25646180 · DOI 10.1158/1078-0432.ccr-14-0507 -
Molecular pathways and targets in prostate cancer.
Shtivelman E, Beer TM, Evans CP. · · 2014 · cited 81× · PMID 25277175 · DOI 10.18632/oncotarget.2406 -
Cooperative integration between HEDGEHOG-GLI signalling and other oncogenic pathways: implications for cancer therapy.
Pandolfi S, Stecca B. · · 2015 · cited 66× · PMID 25660620 · DOI 10.1017/erm.2015.3 -
The role of Hedgehog and Notch signaling pathway in cancer.
Xia R, Xu M, Yang J, Ma X. · · 2022 · cited 39× · PMID 36517618 · DOI 10.1186/s43556-022-00099-8 -
Phosphodiesterase 4D inhibitors limit prostate cancer growth potential.
Powers GL, Hammer KD, Domenech M, Frantskevich K, et al · · 2015 · cited 39× · PMID 25149359 · DOI 10.1158/1541-7786.mcr-14-0110 -
Clinical Implications of Hedgehog Pathway Signaling in Prostate Cancer.
Suzman DL, Antonarakis ES. · · 2015 · cited 21× · PMID 26426053 · DOI 10.3390/cancers7040871
Verify or expand the search:
- PubMed search for NCT01163084
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01163084 (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 National Cancer Institute (NCI)
- Last refreshed: 28 February 2019
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/NCT01163084.
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