A Phase II, Randomized, Open-Label Study of Neoadjuvant Degarelix versus LHRH Agonist in Prostate Cancer Patients Prior to Radical Prostatectomy.

Sayyid RK, Evans A, Hersey K, Maloni R, Hurtado-Coll A, Kulkarni G, Finelli A, Zlotta AR, Hamilton R, Gleave M, Fleshner NE

Clinical cancer research : an official journal of the American Association for Cancer Research18 Oct 2016Cited by 31 (Europe PMC)

PMID27756786DOI10.1158/1078-0432.ccr-16-1790PepBankPUB-27756786

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In localized prostate cancer, intratumoral DHT was higher in the degarelix-only arm than in the degarelix/bicalutamide arm (0.87 versus 0.26 ng/g, P < 0.01).
In plain wordsIn localized prostate cancer, intratumoral DHT was higher with degarelix alone than with degarelix/bicalutamide.
Peptide
Degarelix
Outcome
IncreaseIntratumoral DHT
Study
n: not reported in source
Comparator
Degarelix/bicalutamide
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · 3 monthsAs given in this study (human).
Measurements
Intratumoral DHT
0.87 ng/g
degarelix-only arm; P < 0.01 versus both combination arms
Intratumoral DHT
0.26 ng/g
degarelix/bicalutamide arm
Intratumoral DHT
0.23 ng/g
LHRH agonist/bicalutamide arm
Source sentences
Summary
Intratumoral DHT levels were higher in the degarelix arm than both the degarelix/bicalutamide and LHRH agonist/bicalutamide arms (0.87 ng/g vs. 0.26 ng/g and 0.23 ng/g, P < 0.01).
3 context sentences(design, population, supporting numbers)
Summary · context
Thirty-nine patients were randomly assigned to one of three different neoadjuvant arms: degarelix only, degarelix/bicalutamide, or LHRH agonist/bicalutamide.
Summary · context
Treatments were given for 3 months before prostatectomy.
Summary · context
Patients had localized prostate cancer and had chosen radical prostatectomy as primary treatment.
Report a problemFND-2775678601
02HumanRandomized controlled trialEfficacy outcome
In localized prostate cancer, intratumoral DHT was higher in the degarelix-only arm than in the LHRH agonist/bicalutamide arm (0.87 versus 0.23 ng/g, P < 0.01).
In plain wordsIn localized prostate cancer, intratumoral DHT was higher with degarelix alone than with LHRH agonist/bicalutamide.
Peptide
Degarelix
Outcome
IncreaseIntratumoral DHT
Study
n: not reported in source
Comparator
LHRH agonist/bicalutamide
Analysis
Primary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · 3 monthsAs given in this study (human).
Measurements
Intratumoral DHT
0.87 ng/g
degarelix-only arm; P < 0.01 versus both combination arms
Intratumoral DHT
0.26 ng/g
degarelix/bicalutamide arm
Intratumoral DHT
0.23 ng/g
LHRH agonist/bicalutamide arm
Source sentences
Summary
Intratumoral DHT levels were higher in the degarelix arm than both the degarelix/bicalutamide and LHRH agonist/bicalutamide arms (0.87 ng/g vs. 0.26 ng/g and 0.23 ng/g, P < 0.01).
3 context sentences(design, population, supporting numbers)
Summary · context
Thirty-nine patients were randomly assigned to one of three different neoadjuvant arms: degarelix only, degarelix/bicalutamide, or LHRH agonist/bicalutamide.
Summary · context
Treatments were given for 3 months before prostatectomy.
Summary · context
Patients had localized prostate cancer and had chosen radical prostatectomy as primary treatment.
Report a problemFND-2775678602
03HumanRandomized controlled trialEfficacy outcome
In localized prostate cancer, intratumoral testosterone did not differ significantly between treatment arms including degarelix alone.
In plain wordsIn localized prostate cancer, intratumoral testosterone did not differ significantly between degarelix alone and the other arms.
Peptide
Degarelix
Outcome
No significant changeIntratumoral testosterone
Study
n = 39
Comparator
Degarelix/bicalutamide and LHRH agonist/bicalutamide
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · 3 monthsAs given in this study (human).
Source sentences
Summary
No significant differences existed for other intratumoral androgens, such as testosterone and dehydroepiandrosterone.
3 context sentences(design, population, supporting numbers)
Summary · context
Thirty-nine patients were randomly assigned to one of three different neoadjuvant arms: degarelix only, degarelix/bicalutamide, or LHRH agonist/bicalutamide.
Summary · context
Treatments were given for 3 months before prostatectomy.
Summary · context
Patients had localized prostate cancer and had chosen radical prostatectomy as primary treatment.
Report a problemFND-2775678603
04HumanRandomized controlled trialEfficacy outcome
In localized prostate cancer, intratumoral dehydroepiandrosterone did not differ significantly between treatment arms including degarelix alone.
In plain wordsIn localized prostate cancer, intratumoral dehydroepiandrosterone did not differ significantly between degarelix alone and the other arms.
Peptide
Degarelix
Outcome
No significant changeIntratumoral dehydroepiandrosterone
Study
n = 39
Comparator
Degarelix/bicalutamide and LHRH agonist/bicalutamide
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · 3 monthsAs given in this study (human).
Source sentences
Summary
No significant differences existed for other intratumoral androgens, such as testosterone and dehydroepiandrosterone.
3 context sentences(design, population, supporting numbers)
Summary · context
Thirty-nine patients were randomly assigned to one of three different neoadjuvant arms: degarelix only, degarelix/bicalutamide, or LHRH agonist/bicalutamide.
Summary · context
Treatments were given for 3 months before prostatectomy.
Summary · context
Patients had localized prostate cancer and had chosen radical prostatectomy as primary treatment.
Report a problemFND-2775678604
05HumanRandomized controlled trialEfficacy outcome
In localized prostate cancer, the degarelix-only arm had higher AMACR levels on immunohistochemistry (P = 0.01).
In plain wordsIn localized prostate cancer, the degarelix-only arm had higher AMACR levels on tissue analysis.
Peptide
Degarelix
Outcome
IncreaseAMACR levels
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 3 monthsAs given in this study (human).
Source sentences
Summary
Patients in the degarelix-only arm had higher AMACR levels on immunohistochemical analysis (P = 0.01).
3 context sentences(design, population, supporting numbers)
Summary · context
Thirty-nine patients were randomly assigned to one of three different neoadjuvant arms: degarelix only, degarelix/bicalutamide, or LHRH agonist/bicalutamide.
Summary · context
Treatments were given for 3 months before prostatectomy.
Summary · context
Patients had localized prostate cancer and had chosen radical prostatectomy as primary treatment.
Report a problemFND-2775678605
06HumanRandomized controlled trialEfficacy outcome
In localized prostate cancer, serum FSH was lower after 12 weeks with degarelix alone than with LHRH agonist/bicalutamide.
In plain wordsIn localized prostate cancer, serum FSH was lower with degarelix alone than with LHRH agonist/bicalutamide.
Peptide
Degarelix
Outcome
DecreaseSerum FSH
Study
n: not reported in source
Comparator
LHRH agonist/bicalutamide
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · 3 monthsAs given in this study (human).
Measurements
Serum FSH
0.55
degarelix only, 12 weeks
Serum FSH
3.65
LHRH agonist/bicalutamide, 12 weeks
P
< 0.01
both degarelix arms vs LHRH agonist/bicalutamide
Source sentences
Summary
Serum FSH levels were lower after 12 weeks of therapy in both degarelix arms than the LHRH agonist/bicalutamide arm (0.55 and 0.65 vs. 3.65, P < 0.01)
3 context sentences(design, population, supporting numbers)
Summary · context
Thirty-nine patients were randomly assigned to one of three different neoadjuvant arms: degarelix only, degarelix/bicalutamide, or LHRH agonist/bicalutamide.
Summary · context
Treatments were given for 3 months before prostatectomy.
Summary · context
Patients had localized prostate cancer and had chosen radical prostatectomy as primary treatment.
Report a problemFND-2775678606
07HumanRandomized controlled trialEfficacy outcome
In localized prostate cancer, serum FSH after 12 weeks was lower with degarelix/bicalutamide than LHRH agonist/bicalutamide (0.65 versus 3.65, P < 0.01).
In plain wordsIn localized prostate cancer, degarelix with bicalutamide lowered FSH more than an LHRH agonist with bicalutamide.
Peptide
Degarelix
Outcome
DecreaseSerum FSH with bicalutamide background
Study
n: not reported in source
Comparator
LHRH agonist/bicalutamide
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · 3 monthsAs given in this study (human).
Measurements
Serum FSH
0.65
degarelix/bicalutamide, 12 weeks
Serum FSH
3.65
LHRH agonist/bicalutamide, 12 weeks
P
< 0.01
both degarelix arms vs LHRH agonist/bicalutamide
Source sentences
Summary
Serum FSH levels were lower after 12 weeks of therapy in both degarelix arms than the LHRH agonist/bicalutamide arm (0.55 and 0.65 vs. 3.65, P < 0.01)
3 context sentences(design, population, supporting numbers)
Summary · context
Thirty-nine patients were randomly assigned to one of three different neoadjuvant arms: degarelix only, degarelix/bicalutamide, or LHRH agonist/bicalutamide.
Summary · context
Treatments were given for 3 months before prostatectomy.
Summary · context
Patients had localized prostate cancer and had chosen radical prostatectomy as primary treatment.
Report a problemFND-2775678607
08HumanRandomized controlled trialEfficacy outcome
In localized prostate cancer, inhibin B was lower with degarelix/bicalutamide than LHRH agonist/bicalutamide (82.14 versus 126.67, P = 0.02).
In plain wordsIn localized prostate cancer, inhibin B was lower with degarelix and bicalutamide than with an LHRH agonist and bicalutamide.
Peptide
Degarelix
Outcome
DecreaseInhibin B with bicalutamide background
Study
n: not reported in source
Comparator
LHRH agonist/bicalutamide
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · 3 monthsAs given in this study (human).
Measurements
Inhibin B
82.14
degarelix/bicalutamide arm
Inhibin B
126.67
LHRH agonist/bicalutamide arm
P
0.02
degarelix/bicalutamide vs LHRH agonist/bicalutamide
Source sentences
Summary
inhibin B levels were lower in the degarelix/bicalutamide arm than the LHRH agonist/bicalutamide arm (82.14 vs. 126.67, P = 0.02).
3 context sentences(design, population, supporting numbers)
Summary · context
Thirty-nine patients were randomly assigned to one of three different neoadjuvant arms: degarelix only, degarelix/bicalutamide, or LHRH agonist/bicalutamide.
Summary · context
Treatments were given for 3 months before prostatectomy.
Summary · context
Patients had localized prostate cancer and had chosen radical prostatectomy as primary treatment.
Report a problemFND-2775678608

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT01674270

Degarelix Neo-Adjuvant Radical Prostatectomy Trial

University Health Network, Toronton = 35Aug 2012 to Nov 2015

Prostate Cancer

Trial page ClinicalTrials.govUpdated 22 Dec 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

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