CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Leuprolide Acetate +4 moredrug
Likely dose
Leuprolide 22.5 mg IM every 3 months; Docetaxel 75 mg/m2 IV day 1 every 3 weeks (up to 6 cycles); Bicalutamide 50 mg daily; Stereotactic radiation 16-24 Gy in 1 fraction or 48-50 Gy in multiple fractions; Abiraterone 1000 mg daily (at investigator discretion)AI-extracted
Key inclusion· 5
  • ✓Age ≥18 years
  • ✓ECOG performance status ≤2
  • ✓Histologically confirmed prostate adenocarcinoma
  • ✓Oligometastatic disease: Stage T1-4, N0-1, M1a-b with up to 5 metastatic lesions (bone or non-regional lymph nodes)
Key exclusion· 8
  • ✕Prior local non-surgical therapy for prostate cancer (radiation, brachytherapy)
  • ✕Prior systemic therapy for prostate cancer including hormonal therapy, CYP-17 inhibitors, antiandrogens, second-generation antiandrogens, immunotherapy, or chemotherapy (exception: hormone therapy started <90 days prior)
  • ✕Prior therapy to any metastatic site
  • ✕Abnormal bone marrow: ANC <1500/mm3, platelets <100,000/mm3, hemoglobin <9 g/dL

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

Search/NCT03043807
NCT03043807Phase 2Completed
CompareCT.gov

A Phase II Study of Definitive Therapy for Newly Diagnosed Men With Oligometastatic Prostate Cancer After Prostatectomy

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Feb 6, 2017·Updated Feb 16, 2023

In Brief

A Phase 2 clinical trial evaluating Leuprolide Acetate, Docetaxel, and 3 other interventions for Prostate Cancer. Completed, enrolled 26 participants across 2 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 adjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years 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
2017201820192020202120222023202420252026
First PostedFeb 6, 2017
Enrollment StartFeb 22, 2017
Primary CompletionOct 17, 2022
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 9.4 years ago

Interventions

Leuprolide Acetatedrug

22.5mg by intramuscular (IM) injection every 3 months

Docetaxeldrug

75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.

Bicalutamidedrug

bicalutamide (Casodex) 50mg by mouth daily

Radiationradiation

Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.

Abiraterone Acetatedrug

Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.