Phase 2
N=62
Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01630590 ↗Enrolled (actual)
62
Serious AEs
4.8%
Results posted
Mar 2022
Primary outcome: Primary: Progression Free Survival — 16.1 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cabozantinib (Drug); Androgen Ablation Therapy (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Male
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
16.1 | — |
| PRIMARY Serious Adverse Events and Other (Not Including Serious) Adverse Events |
2105; 3 | — |
Summary
The goal of this clinical research study is learn if adding cabozantinib (also known as XL184) to hormonal therapy can help to control prostate cancer. The safety of this drug will also be studied.
Cabozantinib is designed to block certain proteins in your blood that cause cancer cells to grow. This may cause cancer cells to die.
Eligibility Criteria
Inclusion Criteria
- Histologic proof of prostate adenocarcinoma
- Newly diagnosed Androgen-Dependent Prostate Cancer. Patients already on ADT are eligible as long as the time from initiation of LHRH analog or antagonist is not greater than 3 months.
- Metastatic disease on bone scan and/or involvement of soft tissues (lymph nodes and/or viscera) by CT scan, PET/CT, or MRI
- PSA > 1 ng/ml, unless anaplastic features are present (according to eligibility 10)
- Life expectancy from a co-morbid illness > 3 years
- Eastern Cooperative Oncology Group (ECOG) performance status /= 1,500/ul (unless due to bone marrow infiltration by tumor in which case ANC >/=500/ml are allowed) Hemoglobin (Hgb) >/= 9 gm/dL (unless due to bone marrow infiltration by tumor in which case Hgb>8 gm/dL); Total bilirubin /= 100,000/mm^3 (unless due to bone marrow infiltration by tumor in which case >/=50,000/ml are allowed); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) /= lower limits of normal (LLN); estimated creatinine clearance of >/=40 ml/min.
- Prior ADT is allowed if it was an adjunct to definite local therapy, was given for 5 cm in longest dimension) lymphadenopathy or high-grade (gleason >8) tumor mass in the prostate/pelvis.; b) Low PSA ( /=20) bone metastases.; c) Elevated serum LDH (>/= 2 x ULN) or elevated serum CEA (>/= 2 x ULN) in the absence of other etiologies.; d) Short interval ( /= 7.5mg/day prednisone (or prednisone equivalents).
- Prior treatment with cabozantinib.
- The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) >500 ms within 28 days before randomization.
Data sourced from ClinicalTrials.gov (NCT01630590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.