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

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT01731912
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 16
• Location: 1
• Arm: 1
• Duration (Months): 40
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Adenocarcinoma; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer	Drug: Degarelix; Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. To evaluate the effect of neoadjuvant degarelix (degarelix acetate) on prostate dihydrotestosterone (DHT) and testosterone levels.

SECONDARY OBJECTIVES:

1. To determine the effect of degarelix acetate on androgen-regulated gene expression and apoptosis as assessed by immunohistochemistry, complementary deoxyribonucleic acid (cDNA) microarray analysis and reverse transcriptase (RT)-polymerase chain reaction (PCR).

2. To determine the effect of degarelix acetate on follicle stimulating hormone (FSH) and FSH receptor expression in prostate cancer and surrounding microenvironment.

OUTLINE:

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Degarelix Acetate Prior to Radiation Therapy
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Degarelix; Given SC; Other Names: FE200486 Firmagon ; Radiation: External Beam Radiation Therapy; Undergo standard EBRT; Other Names: Definitive Radiation Therapy EBRT External Beam Radiotherapy External Beam RT external radiation External Radiation Therapy external-beam radiation ; Other: Laboratory Biomarker Analysis; Correlative studies

Outcome Measures

Primary Outcome Measures

1. Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry [At week 24]

   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 [At week 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington	United States	98109

Sponsors and Collaborators

• University of Washington
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Robert Montgomery, Fred Hutch/University of Washington Cancer Consortium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bruce Montgomery, Principal Investigator, University of Washington
• ClinicalTrials.gov Identifier: NCT01731912
• Other Study ID Numbers: 7846; NCI-2012-02136; RAD2; 7846; P30CA015704
• First Posted: Nov 22, 2012
• Last Update Posted: Jan 18, 2019
• Last Verified: Dec 1, 2018

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Pre-assignment Detail	16 started therapy. 14 completed therapy

Arm/Group Title	Degarelix
Arm/Group Description	Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
Period Title: Overall Study
STARTED	16
COMPLETED	14
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Degarelix
Arm/Group Description	Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
Overall Participants	16
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	65 (5)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	16 100%

Outcome Measures

1. Primary Outcome

Title	Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry
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.
Time Frame	At week 24

Outcome Measure Data

Analysis Population Description

Tissue DHT at 24 weeks

Arm/Group Title	Degarelix
Arm/Group Description	Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
Measure Participants	14
Median (Standard Deviation) [pg/mg]	0.6 (0.34)

2. Primary Outcome

Title	Tissue Levels of Testosterone in Prostate Tissue as Measured by Mass Spectometry
Time Frame	At week 24

Outcome Measure Data

Analysis Population Description

Tissue testosterone levels at 24 weeks

Arm/Group Title	Degarelix
Arm/Group Description	Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
Measure Participants	14
Median (Standard Deviation) [pg/mg]	0.17 (0.13)

Adverse Events

Adverse Event Reporting Description	Degarelix is FDA approved for hormonal treatment of prostate cancer and concurrent administration with radiotherapy in this study and is not considered outside of the standard of care; reporting adverse events was not required. Per the protocol AE reporting was not planned, therefore no AE data was collected.
Arm/Group Title	Degarelix
Arm/Group Description	Patients receive 3 months of degarelix prior to radiation and then for 3 months during radiation. Subsequent therapy is determined by the treating physician
All Cause Mortality
	Degarelix
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Degarelix
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Degarelix
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.