CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Leuprolide Acetate +4 moredrug
Likely dose
Leuprolide Acetate 22.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02716974
NCT02716974Phase 2Completed
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A Phase II Study of Definitive Therapy for Newly Diagnosed Men With Oligometastatic Prostate Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Mar 23, 2016·Updated Aug 4, 2022

In Brief

A Phase 2 clinical trial evaluating Leuprolide Acetate, Bicalutamide, and 3 other interventions for Prostate Cancer. Completed, enrolled 26 participants across 3 sites.

Detailed Summary

To assess the safety of treating men with oligometastatic prostate cancer with the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade will be the same throughout the course of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 23, 2016
Enrollment StartJun 1, 2016
Primary CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 10.3 years ago

Interventions

Leuprolide Acetatedrug

22.5mg by intramuscular (IM) injection every 3 months

Bicalutamidedrug

bicalutamide (Casodex) 50mg by mouth daily

Docetaxeldrug

Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.

Prostatectomyprocedure

Removal of the entire prostate gland, plus some surrounding tissue.

Radiationradiation

5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.