Skip to content

Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study of Definitive Therapy to Treat Prostate Cancer

Short name oligo-mets

NCTNCT02716974 (opens ClinicalTrials.gov in a new tab)Other idJ1618Other idIRB00070003

Overview

Status
Completed
Phase
Phase 2
Enrollment
26 participants (actual)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jun 2016
Primary completion
Apr 2022
Completion
Apr 2022
First posted
23 Mar 2016 (estimated)
Last update posted
4 Aug 2022
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201820202022
  1. Ph 2

    oligo-mets

    NCT02716974

    Jun 2016 to Apr 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Leuprolide AcetateDrug
  • BicalutamideDrug
  • DocetaxelDrug
  • ProstatectomyProcedure
  • RadiationRadiation

Arms1

  • Experimental

    chemohormonal and definitive therapy

    (1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (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 (Bicalutamide) will be the same throughout the course of treatment.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Efficacy as Assessed by 2-year PSA Progression-free Survival Rate

    Time frame · 2 years

    Registry description

    To evaluate efficacy of multimodality therapy in men, defined as the 2 year PSA progression-free (PSA\<0.2 ng/ml) survival among men who have non-castrate testosterone levels 2 years after enrollment. Number of participants (who have non-castrate testosterone levels 2 years after enrollment) with PSA progression-free survival.

Secondary outcomes(2)
  1. Safety of the Multimodality Therapy as Assessed by Number of Participants With Neutropenia and Surgical or Radiation Toxicities

    Time frame · 3 years

    Registry description

    To assess the safety and therapeutic benefit of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer (\<5 sites of metastases). Safety is defined as the incidence of Grades 3 and 4 neutropenia and surgical- or radiation-induced toxicities. Neutropenia is a lower than normal number of neutrophils (a type of white blood cell) in the blood. Although dependent on the specific laboratory, the normal number is of neutrophils is generally about 1500-7800 cells/microliter. Grade 3 and 4 neutropenia refer to neutrophil levels \<1,000-500 and \<500, respectively. The average risk of docetaxel-induced Grade 3 and 4 neutropenia is about 35%. During the course of the study, if we had seen evidence that the risk of Grade 3 and 4 neutropenia was \>50%, the study would have been stopped.

  2. Time to Prostate-specific Antigen Recurrence

    Time frame · 3 years

    Registry description

    To investigate the time from an undetectable prostate-specific antigen (≤0.2 ng/mL) until the prostate-specific antigen is \>0.2 over two time-points.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 2 years

Efficacy as Assessed by 2-year PSA Progression-free Survival Rate

GroupValue (Participants)
Chemohormonal and Definitive Therapy17
Secondary and other outcome results(2)
Secondary outcomeCount of participants· 3 years

Safety of the Multimodality Therapy as Assessed by Number of Participants With Neutropenia and Surgical or Radiation Toxicities

GroupValue (Participants)
Chemohormonal and Definitive Therapy26
Secondary outcomeMedian· 3 years

Time to Prostate-specific Antigen Recurrence

GroupValue (Months)
Chemohormonal and Definitive Therapy31

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Chemohormonal and Definitive Therapy(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (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 (Bicalutamide) will be the same throughout the course of treatment. Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily Docetaxel: Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Prostatectomy: Removal of the entire prostate gland, plus some surrounding tissue. Radiation: 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.0 / 262 / 2626 / 26

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Willing and able to provide written informed consent. * Age ≥ 18 years * Eastern cooperative group (ECOG) performance status ≤2 * Documented histologically confirmed adenocarcinoma of the prostate * Willing to undergo 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. Additionally, must be willing to be treated with a full year of androgen deprivation. * Oligometastatic prostate cancer: Stage T1-4, N0-1 and/or M1a-b (up to 5 metastatic lesions- including bone lesions and non-regional lymph nodes seen on bone scan, contrast enhanced CT scan, or positron emission tomography scan) * Able to swallow the study drugs whole as tablets Exclusion Criteria: * Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy) * Prior therapy to a metastatic site. * Prior or ongoing systemic therapy for prostate cancer including, but not limited to: 1. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix) 2. Cytochrome (CYP) -17 inhibitors (e.g. ketoconazole) 3. Antiandrogens (e.g. bicalutamide, nilutamide) 4. Second generation antiandrogens (e.g. enzalutamide, abiraterone) 5. Immunotherapy (e.g. sipuleucel-T, ipilimumab) 6. Chemotherapy (e.g. docetaxel, cabazitaxel) \*Note: may be enrolled if hormone therapy was recently initiated (\<90 days duration). In the event that hormone therapy was initiated prior to study enrollment, the clock for 1 year of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment. * Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study. * Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule. * Abnormal bone marrow function \[absolute neutrophil count (ANC)\<1500/mm3, platelet count \<100,000/mm3, hemoglobin \<9 g/dL\] * Abnormal liver function (bilirubin \>upper limit of normal; aspartate aminotransferase , alanine aminotransferase \> 2.5 x upper limit of normal) * Creatinine clearance of ≥ 30 mL/min. Creatinine clearance should be calculated suing the Cockcroft-Gault formula. * Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months. * Prior history of malignancy in the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin. Other malignancies that are considered to have a low potential to progress may be enrolled at discretion of PI.

PepBank is a research reference. Talk to a doctor before you use any peptide.