Prostate Cancer > Docetaxel
~59 spots leftby Apr 2026

DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])

Recruiting in Palo Alto (17 mi)
+222 other locations
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Novacea
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of this study is: * To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer The secondary objectives of this study are: * To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots) * To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures) * A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.

Research Team

HI

Howard I. Scher, MD

Principal Investigator

Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan Kettering Cancer Center

KN

Kim N. Chi, M.D.

Principal Investigator

British Columbia Cancer Agency - Vancouver Centre

RD

Ronald De-Wit, M.D.

Principal Investigator

Erasmus University Medical Center (Netherlands)

Eligibility Criteria

Inclusion Criteria

Histopathologically or cytologically proven adenocarcinoma of the prostate
Documented metastatic prostate adenocarcinoma
Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
See 4 more

Treatment Details

Interventions

  • DN-101 (Vitamin D Analog)
  • Docetaxel (Taxane)

Docetaxel is already approved in Canada, Japan for the following indications:

🇨🇦
Approved in Canada as Taxotere for:
  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Prostate Cancer
🇯🇵
Approved in Japan as Taxotere for:
  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Prostate Cancer

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Alaska Clinical Research CenterAnchorage, AK
UCLA department of UrologyLos Angeles, CA
Sutter Gould Medical FoundationModesto, CA
Sharp Memorial HospitalSan Diego, CA
More Trial Locations
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Who Is Running the Clinical Trial?

Novacea

Lead Sponsor

Trials
11
Patients Recruited
2,000+
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