Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31.

Pilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D

Journal of clinical oncology : official journal of the American Society of Clinical Oncology1 Mar 1997Cited by 399 (Europe PMC)

PMID9060541DOI10.1200/jco.1997.15.3.1013PepBankPUB-09060541

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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 study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In irradiated prostate cancer patients, freedom from local recurrence at 5 years was 84% with adjuvant goserelin versus 71% with observation.
In plain wordsIn irradiated prostate cancer patients, freedom from local recurrence at 5 years was higher with goserelin than observation.
Peptide
Goserelin
Outcome
IncreaseFreedom from local recurrence at 5 years
Study
n = 945
Comparator
Observation after definitive radiotherapy
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated
Measurements
Freedom from local recurrence
84%
goserelin at 5 years
Freedom from local recurrence
71%
observation at 5 years
Source sentences
Summary
Actuarial projections show that at 5 years, 84% of patients on the adjuvant goserelin arm and 71% on the observation arm remain without evidence of local recurrence (P < .0001).
2 context sentences(design, population, supporting numbers)
Summary · context
In 1987, the Radiation Therapy Oncology Group (RTOG) initiated a randomized phase III trial of adjuvant goserelin in definitively irradiated patients with carcinoma of the prostate.
Summary · context
Of these, 945 remained analyzable: 477 on the adjuvant arm and 468 on the observation arm.
Report a problemFND-0906054101
02HumanRandomized controlled trialEfficacy outcome
In irradiated prostate cancer patients, freedom from distant metastases at 5 years was 83% with goserelin versus 70% with observation.
In plain wordsIn irradiated prostate cancer patients, freedom from distant metastases at 5 years was higher with goserelin than observation.
Peptide
Goserelin
Outcome
IncreaseFreedom from distant metastases at 5 years
Study
n = 945
Comparator
Observation after definitive radiotherapy
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated
Measurements
Freedom from distant metastases
83%
goserelin at 5 years
Freedom from distant metastases
70%
observation at 5 years
Source sentences
Summary
The corresponding figures for freedom from distant metastases and disease-free survival are 83% versus 70% (P < .001) and 60% and 44% (P < .0001).
3 context sentences(design, population, supporting numbers)
Summary · context
Actuarial projections show that at 5 years, 84% of patients on the adjuvant goserelin arm and 71% on the observation arm remain without evidence of local recurrence (P < .0001).
Summary · context
In 1987, the Radiation Therapy Oncology Group (RTOG) initiated a randomized phase III trial of adjuvant goserelin in definitively irradiated patients with carcinoma of the prostate.
Summary · context
Of these, 945 remained analyzable: 477 on the adjuvant arm and 468 on the observation arm.
Report a problemFND-0906054102
03HumanRandomized controlled trialEfficacy outcome
In irradiated prostate cancer patients, disease-free survival at 5 years was 60% with goserelin versus 44% with observation.
In plain wordsIn irradiated prostate cancer patients, disease-free survival at 5 years was higher with goserelin than observation.
Peptide
Goserelin
Outcome
IncreaseDisease-free survival at 5 years
Study
n = 945
Comparator
Observation after definitive radiotherapy
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated
Measurements
Disease-free survival
60%
goserelin at 5 years
Disease-free survival
44%
observation at 5 years
Source sentences
Summary
The corresponding figures for freedom from distant metastases and disease-free survival are 83% versus 70% (P < .001) and 60% and 44% (P < .0001).
3 context sentences(design, population, supporting numbers)
Summary · context
Actuarial projections show that at 5 years, 84% of patients on the adjuvant goserelin arm and 71% on the observation arm remain without evidence of local recurrence (P < .0001).
Summary · context
In 1987, the Radiation Therapy Oncology Group (RTOG) initiated a randomized phase III trial of adjuvant goserelin in definitively irradiated patients with carcinoma of the prostate.
Summary · context
Of these, 945 remained analyzable: 477 on the adjuvant arm and 468 on the observation arm.
Report a problemFND-0906054103
04HumanRandomized controlled trialEfficacy outcome
In irradiated prostate cancer patients, 5-year disease-free survival was 53% with goserelin versus 20% with observation when PSA greater than 1.5 ng after at least 1 year counted as failure.
In plain wordsIn irradiated prostate cancer patients, PSA-inclusive disease-free survival at 5 years was higher with goserelin than observation.
Peptide
Goserelin
Outcome
IncreasePSA-inclusive disease-free survival at 5 years
Study
n = 945
Comparator
Observation after definitive radiotherapy
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated
Measurements
Disease-free survival with PSA greater than 1.5 ng counted as failure
53%
goserelin at 5 years
Disease-free survival with PSA greater than 1.5 ng counted as failure
20%
observation at 5 years
Source sentences
Summary
If prostate-specific antigen (PSA) level greater than 1.5 ng is included as a failure (after > or = 1 year), the 5-year disease-free survival rate on the adjuvant goserelin arm is 53% versus 20% on the observation arm (P < .0001).
2 context sentences(design, population, supporting numbers)
Summary · context
In 1987, the Radiation Therapy Oncology Group (RTOG) initiated a randomized phase III trial of adjuvant goserelin in definitively irradiated patients with carcinoma of the prostate.
Summary · context
Of these, 945 remained analyzable: 477 on the adjuvant arm and 468 on the observation arm.
Report a problemFND-0906054104
05HumanRandomized controlled trialEfficacy outcome
In irradiated prostate cancer patients, 5-year survival was 75% with goserelin versus 71% with observation (P = .52).
In plain wordsIn irradiated prostate cancer patients, 5-year survival did not differ significantly between goserelin and observation.
Peptide
Goserelin
Outcome
No significant changeOverall survival at 5 years
Study
n = 945
Comparator
Observation after definitive radiotherapy
Outcome group
Mortality · Cancer
Studied dose
Dose not stated
Measurements
Overall survival
75%
goserelin at 5 years, entire population
Overall survival
71%
observation at 5 years, entire population
Source sentences
Summary
The 5-year survival rate (for the entire population) is 75% on the adjuvant arm versus 71% on the observation arm (P = .52).
2 context sentences(design, population, supporting numbers)
Summary · context
In 1987, the Radiation Therapy Oncology Group (RTOG) initiated a randomized phase III trial of adjuvant goserelin in definitively irradiated patients with carcinoma of the prostate.
Summary · context
Of these, 945 remained analyzable: 477 on the adjuvant arm and 468 on the observation arm.
Report a problemFND-0906054105
06HumanRandomized controlled trialEfficacy outcome
In irradiated patients with centrally reviewed Gleason 8 to 10 prostate tumors, 5-year survival was 66% with goserelin versus 55% with observation.
In plain wordsIn irradiated patients with centrally reviewed Gleason 8 to 10 prostate tumors, 5-year survival was higher with goserelin than observation.
Peptide
Goserelin
Outcome
IncreaseSurvival in centrally reviewed Gleason 8 to 10 tumors
Study
n: not reported in source
Comparator
Observation after definitive radiotherapy
Outcome group
Mortality · Cancer
Studied dose
Dose not stated
Measurements
Overall survival
66%
goserelin at 5 years, centrally reviewed Gleason 8 to 10 tumors
Overall survival
55%
observation at 5 years, centrally reviewed Gleason 8 to 10 tumors
Source sentences
Summary
However, in patients with centrally reviewed tumors with a Gleason score of 8 to 10, the difference in actuarial 5-year survival (66% on the adjuvant goserelin arm v 55% on the observation arm) reaches statistical significance (P = .03).
2 context sentences(design, population, supporting numbers)
Summary · context
In 1987, the Radiation Therapy Oncology Group (RTOG) initiated a randomized phase III trial of adjuvant goserelin in definitively irradiated patients with carcinoma of the prostate.
Summary · context
Of these, 945 remained analyzable: 477 on the adjuvant arm and 468 on the observation arm.
Report a problemFND-0906054106

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 stopped early · source ClinicalTrials.gov (opens in a new tab)

TerminatedPhase 3NCT00243646

Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial

Schiffler Cancer Centern = 6Aug 2004 to Jul 2009

Prostate Cancer

Trial page ClinicalTrials.govUpdated 14 Apr 2016

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, 16:35 UTC
First added · source update from Europe PMC

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