Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy.

Autio KA, Antonarakis ES, Mayer TM, Shevrin DH, Stein MN, Vaishampayan UN, Morris MJ, Slovin SF, Heath EI, Tagawa ST, Rathkopf DE, Milowsky MI and 15 more

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Harrison MR, Beer TM, Balar AV, Armstrong AJ, George DJ, Paller CJ, Apollo A, Danila DC, Graff JN, Nordquist L, Dayan Cohn ES, Tse K, Schreiber NA, Heller G, Scher HI

European urology open science17 Nov 2021Cited by 17 (Europe PMC)

PMID34934969PMCIDPMC8655386DOI10.1016/j.euros.2021.09.015PepBankPUB-34934969

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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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In men with recurrence after prostatectomy, adding degarelix to AAP did not change undetectable PSA with testosterone >150 ng/dl at 18 months (17.1% versus 5.1%, p = 0.93).
In plain wordsIn recurrent prostate cancer, adding degarelix to AAP did not change undetectable PSA with testosterone above 150 ng/dl at 18 months.
Peptide
Degarelix
Outcome
No significant changePrimary response with addition of degarelix to AAP
Study
n: not reported in source
Comparator
Abiraterone acetate plus prednisone alone
Analysis
Primary
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 8 moAs given in this study (human).
Measurements
Undetectable PSA with testosterone >150 ng/dl at 18 mo
17.1%
AAP plus degarelix (arm 2)
Undetectable PSA with testosterone >150 ng/dl at 18 mo
5.1%
AAP alone (arm 1)
Source sentences
Summary
For the 122 patients enrolled, no difference was found between treatments for the primary endpoint (arm 1: 5.1% [95% confidence interval {CI}: 1-17%], arm 2: 17.1% [95% CI: 7-32%], arm 3: 11.9% [95% CI: 4-26%]; arm 1 vs 2, p = 0.93; arm 2 vs 3, p = 0.36).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was undetectable PSA with testosterone >150 ng/dl at 18 mo.
Summary · context
Patients with BCR (prostate-specific antigen [PSA] ≥1.0 ng/ml, PSA doubling time ≤9 mo, no metastases on standard imaging, and testosterone ≥150 ng/dl) after prostatectomy (with or without prior radiotherapy) were included in this study.
Summary · context
Patients were randomized to AAP (arm 1), AAP with degarelix (arm 2), or degarelix (arm 3) for 8 mo, and monitored for 18 mo.
Report a problemFND-3493496902
02HumanRandomized controlled trialEfficacy outcome
In men with recurrence after prostatectomy, undetectable PSA with testosterone >150 ng/dl at 18 months did not differ between degarelix (11.9%) and AAP (5.1%).
In plain wordsIn recurrent prostate cancer, degarelix and AAP did not differ in undetectable PSA with testosterone above 150 ng/dl at 18 months.
Peptide
Degarelix
Outcome
No significant changeUndetectable PSA with testosterone recovery versus AAP
Study
n: not reported in source
Comparator
Abiraterone acetate plus prednisone alone
Analysis
Primary
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 8 moAs given in this study (human).
Measurements
Undetectable PSA with testosterone >150 ng/dl at 18 mo
11.9%
degarelix alone (arm 3)
Undetectable PSA with testosterone >150 ng/dl at 18 mo
5.1%
AAP alone (arm 1)
Source sentences
Summary
For the 122 patients enrolled, no difference was found between treatments for the primary endpoint (arm 1: 5.1% [95% confidence interval {CI}: 1-17%], arm 2: 17.1% [95% CI: 7-32%], arm 3: 11.9% [95% CI: 4-26%]; arm 1 vs 2, p = 0.93; arm 2 vs 3, p = 0.36).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was undetectable PSA with testosterone >150 ng/dl at 18 mo.
Summary · context
Patients were randomized to AAP (arm 1), AAP with degarelix (arm 2), or degarelix (arm 3) for 8 mo, and monitored for 18 mo.
Summary · context
Patients with BCR (prostate-specific antigen [PSA] ≥1.0 ng/ml, PSA doubling time ≤9 mo, no metastases on standard imaging, and testosterone ≥150 ng/dl) after prostatectomy (with or without prior radiotherapy) were included in this study.
Report a problemFND-3493496905
03HumanRandomized controlled trialEfficacy outcome
In men with biochemical recurrence after prostatectomy, testosterone recovery took longer with degarelix than AAP (52.9 versus 36.0 weeks, p < 0.001).
In plain wordsIn men with recurrent prostate cancer after surgery, testosterone recovery took longer with degarelix than with AAP.
Peptide
Degarelix
Outcome
IncreaseTime to testosterone recovery
Study
n: not reported in source
Comparator
Abiraterone acetate plus prednisone
Analysis
Secondary
Outcome group
Sex hormones and fertility · Endocrine and hormones
Studied dose
Dose not stated · 8 moAs given in this study (human).
Measurements
Median time to testosterone recovery
52.9 weeks
degarelix; 95% CI 49.0-56.0
Median time to testosterone recovery
36 weeks
AAP; 95% CI 35.9-36.1
Source sentences
Summary
AAP therapy showed the shortest median time to testosterone recovery (36.0 wk [95% CI: 35.9-36.1]) relative to degarelix (52.9 wk [95% CI: 49.0-56.0], p < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients with BCR (prostate-specific antigen [PSA] ≥1.0 ng/ml, PSA doubling time ≤9 mo, no metastases on standard imaging, and testosterone ≥150 ng/dl) after prostatectomy (with or without prior radiotherapy) were included in this study.
Summary · context
Patients were randomized to AAP (arm 1), AAP with degarelix (arm 2), or degarelix (arm 3) for 8 mo, and monitored for 18 mo.
Report a problemFND-3493496903
04HumanRandomized controlled trialEfficacy outcome
In men with biochemical recurrence after prostatectomy, undetectable PSA rates at 8 months did not differ significantly between degarelix alone and AAP alone (p = 0.12).
In plain wordsIn men with recurrent prostate cancer after surgery, undetectable PSA rates did not differ significantly between degarelix alone and AAP alone.
Peptide
Degarelix
Outcome
No significant changeUndetectable PSA at 8 months
Study
n: not reported in source
Comparator
Abiraterone acetate plus prednisone alone
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 8 moAs given in this study (human).
Source sentences
Summary
Rates of undetectable PSA at 8 mo differed between AAP with degarelix and degarelix alone (p = 0.04), but not between AAP alone and degarelix alone (p = 0.12).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients with BCR (prostate-specific antigen [PSA] ≥1.0 ng/ml, PSA doubling time ≤9 mo, no metastases on standard imaging, and testosterone ≥150 ng/dl) after prostatectomy (with or without prior radiotherapy) were included in this study.
Summary · context
Patients were randomized to AAP (arm 1), AAP with degarelix (arm 2), or degarelix (arm 3) for 8 mo, and monitored for 18 mo.
Report a problemFND-3493496904
05HumanNon-randomized trialEfficacy outcome
In men with biochemical recurrence after prostatectomy, 11.9% receiving degarelix alone had undetectable PSA with testosterone >150 ng/dl at 18 months (95% CI 4-26%).
In plain wordsIn men with recurrent prostate cancer after surgery, 11.9% receiving degarelix had undetectable PSA with testosterone above 150 ng/dl at 18 months.
Peptide
Degarelix
Outcome
Not applicableUndetectable PSA with testosterone recovery at 18 months
Study
n: not reported in source
Analysis
Primary
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · 8 moAs given in this study (human).
Measurements
Undetectable PSA with testosterone >150 ng/dl at 18 mo
11.9%
degarelix alone (arm 3)
95% CI of rate
4 to 26%
degarelix alone (arm 3)
Source sentences
Summary
For the 122 patients enrolled, no difference was found between treatments for the primary endpoint (arm 1: 5.1% [95% confidence interval {CI}: 1-17%], arm 2: 17.1% [95% CI: 7-32%], arm 3: 11.9% [95% CI: 4-26%]; arm 1 vs 2, p = 0.93; arm 2 vs 3, p = 0.36).
3 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was undetectable PSA with testosterone >150 ng/dl at 18 mo.
Summary · context
Patients with BCR (prostate-specific antigen [PSA] ≥1.0 ng/ml, PSA doubling time ≤9 mo, no metastases on standard imaging, and testosterone ≥150 ng/dl) after prostatectomy (with or without prior radiotherapy) were included in this study.
Summary · context
Patients were randomized to AAP (arm 1), AAP with degarelix (arm 2), or degarelix (arm 3) for 8 mo, and monitored for 18 mo.
Report a problemFND-3493496901

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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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