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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer

NCTNCT01731912 (opens ClinicalTrials.gov in a new tab)Other id7846Other idNCI-2012-02136Other idRAD2Other id7846

Overview

Status
Completed
Phase
Not applicable
Enrollment
16 participants (actual)
Sponsor
University of Washington · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
May 2013
Primary completion
Sept 2016
Completion
Sept 2016
First posted
22 Nov 2012 (estimated)
Last update posted
18 Jan 2019
Conditions
Prostate Adenocarcinoma · Stage IIA Prostate Cancer · Stage IIB Prostate Cancer · Stage III Prostate Cancer · Stage IV Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. N/A

    Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer

    NCT01731912

    May 2013 to Sept 2016

Registry summary

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

This pilot clinical trial studies how well degarelix acetate before and during radiation therapy works in treating patients with prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as degarelix acetate, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving degarelix acetate together with radiation therapy may work better in treating prostate cancer.

Interventions

  • DegarelixDrug
  • External Beam Radiation TherapyRadiation
  • Laboratory Biomarker AnalysisOther

Arms1

  • Experimental

    Treatment (degarelix acetate, EBRT)

    Patients receive degarelix acetate SC on day 1. Treatment repeats every 4 weeks for up to 6 courses. Beginning at week 15, patients also undergo standard EBRT for 8.5 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry

    Time frame · At week 24

    Registry description

    Differences in tissue androgen levels between this group and historical comparisons will be evaluated by performing a one-way analysis of variance (ANOVA), followed by pair-wise two-sample t-tests to determine which groups are statistically different.

  2. Tissue Levels of Testosterone in Prostate Tissue as Measured by Mass Spectometry

    Time frame · At week 24

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 outcomeMedian· At week 24

Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry

GroupValue (pg/mg)Spread
Degarelix0.60.34
Primary outcomeMedian· At week 24

Tissue Levels of Testosterone in Prostate Tissue as Measured by Mass Spectometry

GroupValue (pg/mg)Spread
Degarelix0.170.13

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
DegarelixPatients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician–0 / 00 / 0

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
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Willing and able to provide written informed consent * Written authorization for use and release of health and research study information has been obtained * Histologically proven adenocarcinoma of the prostate * Patients must be candidates for short or long term androgen deprivation in combination with external beam radiation therapy (RT) based on the following criteria: * Intermediate risk disease: T2b/c, or Gleason 7, or prostate-specific antigen (PSA) 10-20 * High risk disease: Gleason 8-10, or PSA \> 20, or T3/4 * Patients may not have received any prior pharmacologic therapy or RT for prostate cancer * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the androgen axis will be determined following review of their case by the principal investigator * Patients must allow biopsy at the time of fiducial placement Exclusion Criteria: * Patients may not be receiving any investigational agents * Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible * Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible * Patients with hypogonadism or severe androgen deficiency as defined by serum testosterone less than 100 ng/dL will not be eligible * History of pituitary dysfunction * Patients who are receiving any androgens, estrogens or progestational agents, or who received any of these agents within the 6 months prior to evaluation will not be eligible * Patients who are taking drugs which affect androgen metabolism (e.g. spironolactone, ketoconazole, finasteride, dutasteride) will not be eligible; patients who received any of these agents within the 6 months prior to evaluation will be reviewed for eligibility by the principal investigator on a case by case basis * Patients with inflammatory bowel disease or other autoimmune conditions which might affect the radiated colon or rectum * Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia which is symptomatic or requires active therapy, recent deep venous thrombosis, pulmonary emboli, cerebrovascular accident or ischemia will not be eligible * Patients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent will not be eligible * Patients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligible * Other active malignancy, except non-melanoma skin cancer and superficial bladder cancer * Patients unwilling to use contraceptives while on study

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