High-dose radiotherapy and risk-adapted androgen deprivation in localised prostate cancer (DART 01/05): 10-year results of a phase 3 randomised, controlled trial.

Zapatero A, Guerrero A, Maldonado X, Álvarez A, San-Segundo CG, Rodríguez MÁC, Solé JM, Olivé AP, Casas F, Boladeras A, de Vidales CM, de la Torre MLV, Vara S, Sanz JL, Calvo FA

The Lancet. Oncology12 Apr 2022Cited by 37 (Europe PMC)

PMID35427469DOI10.1016/s1470-2045(22)00190-5PepBankPUB-35427469

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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 study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In localized prostate cancer, additional goserelin did not significantly improve 10-year biochemical disease-free survival versus short-term treatment.
In plain wordsIn localized prostate cancer, additional goserelin did not significantly improve freedom from biochemical recurrence compared with short-term treatment.
Peptide
Goserelin
Outcome
No significant change10-year biochemical disease-free survival
Study
n = 354
Comparator
Short-term androgen deprivation with high-dose radiotherapy
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · subcutaneous · 24 additional monthsAs given in this study (human).
Measurements
Survival
70.2%
LTAD at 10 years
Survival
62.3%
STAD at 10 years
Hazard ratio
0.84
95% CI 0.5-1.43
P
0.52
comparison
Source sentences
Summary
The 10-year biochemical disease-free survival for LTAD was 70·2% (95% CI 63·1-77·3) and for STAD was 62·3% (54·9-69·7; hazard ratio [HR] 0·84; 95% CI 0·50-1·43; p=0·52).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1) to receive 4 months of neoadjuvant and concomitant short-term androgen deprivation (STAD) plus high-dose radiotherapy (minimum dose 76 Gy; median dose 78 Gy) or to receive the same treatment followed by 24 months of adjuvant long-term androgen deprivation (LTAD),
Summary · context
Patients assigned to LTAD continued with goserelin every 3 months for another 24 months.
Report a problemFND-3542746901
02HumanRandomized controlled trialEfficacy outcome
In localized prostate cancer, additional goserelin did not significantly improve 10-year overall survival versus short-term treatment.
In plain wordsIn localized prostate cancer, additional goserelin did not significantly improve survival compared with short-term treatment.
Peptide
Goserelin
Outcome
No significant change10-year overall survival
Study
n = 354
Comparator
Short-term androgen deprivation with high-dose radiotherapy
Outcome group
Mortality · Cancer
Studied dose
Dose not stated · subcutaneous · 24 additional monthsAs given in this study (human).
Measurements
Survival
78.4%
LTAD at 10 years
Survival
73.3%
STAD at 10 years
Hazard ratio
0.84
95% CI 0.55-1.27
P
0.4
comparison
Source sentences
Summary
At 10 years, overall survival was 78·4% (72·1-84·8) for LTAD and 73·3% (66·6-80·0) for STAD (HR 0·84; 95% CI 0·55-1·27; p=0·40),
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1) to receive 4 months of neoadjuvant and concomitant short-term androgen deprivation (STAD) plus high-dose radiotherapy (minimum dose 76 Gy; median dose 78 Gy) or to receive the same treatment followed by 24 months of adjuvant long-term androgen deprivation (LTAD),
Summary · context
Patients assigned to LTAD continued with goserelin every 3 months for another 24 months.
Report a problemFND-3542746902
03HumanRandomized controlled trialEfficacy outcome
In localized prostate cancer, additional goserelin did not significantly improve 10-year metastasis-free survival versus short-term treatment.
In plain wordsIn localized prostate cancer, additional goserelin did not significantly improve survival without metastases compared with short-term treatment.
Peptide
Goserelin
Outcome
No significant change10-year metastasis-free survival
Study
n = 354
Comparator
Short-term androgen deprivation with high-dose radiotherapy
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · subcutaneous · 24 additional monthsAs given in this study (human).
Measurements
Survival
76%
LTAD at 10 years
Survival
70.9%
STAD at 10 years
Hazard ratio
0.9
95% CI 0.37-2.19
P
0.81
comparison
Source sentences
Summary
and metastasis-free survival was 76·0% (69·4-82·7) for LTAD and 70·9% (64·0-77·8) for STAD (HR 0·90; 95% CI, 0·37-2·19; p=0·81).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1) to receive 4 months of neoadjuvant and concomitant short-term androgen deprivation (STAD) plus high-dose radiotherapy (minimum dose 76 Gy; median dose 78 Gy) or to receive the same treatment followed by 24 months of adjuvant long-term androgen deprivation (LTAD),
Summary · context
Patients assigned to LTAD continued with goserelin every 3 months for another 24 months.
Report a problemFND-3542746903
04HumanRandomized controlled trialEfficacy outcome
In localized prostate cancer, five long-term and six short-term treatment patients died from prostate cancer, all in the high-risk subgroup.
In plain wordsIn localized prostate cancer, prostate cancer deaths numbered five with additional goserelin and six with short-term treatment.
Peptide
Goserelin
Outcome
Not applicableProstate cancer deaths
Study
n = 354
Comparator
Short-term androgen deprivation with high-dose radiotherapy
Outcome group
Mortality · Cancer
Studied dose
Dose not stated · subcutaneous · 24 additional monthsAs given in this study (human).
Measurements
Prostate cancer deaths
5 patients
LTAD group
Prostate cancer deaths
6 patients
STAD group
Prostate cancer deaths
11 patients
both groups; 3% of 354 patients
Source sentences
Summary
Only 11 (3%) of 354 patients died from prostate cancer, all of them in the high-risk subgroup (five in the LTAD group and six in the STAD group).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1) to receive 4 months of neoadjuvant and concomitant short-term androgen deprivation (STAD) plus high-dose radiotherapy (minimum dose 76 Gy; median dose 78 Gy) or to receive the same treatment followed by 24 months of adjuvant long-term androgen deprivation (LTAD),
Summary · context
Patients assigned to LTAD continued with goserelin every 3 months for another 24 months.
Report a problemFND-3542746907
05HumanRandomized controlled trialEfficacy outcome
In high-risk localized prostate cancer, additional goserelin did not significantly improve 10-year biochemical disease-free survival versus short-term treatment.
In plain wordsIn high-risk localized prostate cancer, additional goserelin did not significantly improve freedom from biochemical recurrence compared with short-term treatment.
Peptide
Goserelin
Outcome
No significant changeHigh-risk 10-year biochemical disease-free survival
Study
n: not reported in source
Comparator
Short-term androgen deprivation with high-dose radiotherapy
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · subcutaneous · 24 additional monthsAs given in this study (human).
Measurements
Survival
67.2%
LTAD at 10 years
Survival
53.7%
STAD at 10 years
Hazard ratio
0.9
95% CI 0.49-1.64
P
0.73
comparison
Source sentences
Summary
For the subgroup of high-risk patients, the 10-year biochemical disease-free survival was 67·2% (57·2-77·2) for LTAD and 53·7% (43·3-64·1) for STAD (HR 0·90; 95% CI 0·49-1·64; p=0·73),
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1) to receive 4 months of neoadjuvant and concomitant short-term androgen deprivation (STAD) plus high-dose radiotherapy (minimum dose 76 Gy; median dose 78 Gy) or to receive the same treatment followed by 24 months of adjuvant long-term androgen deprivation (LTAD),
Summary · context
Patients assigned to LTAD continued with goserelin every 3 months for another 24 months.
Report a problemFND-3542746904
06HumanRandomized controlled trialEfficacy outcome
In high-risk localized prostate cancer, additional goserelin did not significantly improve 10-year overall survival versus short-term treatment.
In plain wordsIn high-risk localized prostate cancer, additional goserelin did not significantly improve survival compared with short-term treatment.
Peptide
Goserelin
Outcome
No significant changeHigh-risk 10-year overall survival
Study
n: not reported in source
Comparator
Short-term androgen deprivation with high-dose radiotherapy
Outcome group
Mortality · Cancer
Studied dose
Dose not stated · subcutaneous · 24 additional monthsAs given in this study (human).
Measurements
Survival
78.5%
LTAD at 10 years
Survival
67%
STAD at 10 years
Hazard ratio
0.58
95% CI 0.33-1.01
P
0.054
comparison
Source sentences
Summary
the 10-year overall survival was 78·5% (69·6-87·3) for LTAD and 67·0% (57·3-76·7) for STAD (HR 0·58; 95% CI 0·33-1·01; p=0·054),
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1) to receive 4 months of neoadjuvant and concomitant short-term androgen deprivation (STAD) plus high-dose radiotherapy (minimum dose 76 Gy; median dose 78 Gy) or to receive the same treatment followed by 24 months of adjuvant long-term androgen deprivation (LTAD),
Summary · context
Patients assigned to LTAD continued with goserelin every 3 months for another 24 months.
Report a problemFND-3542746905
07HumanRandomized controlled trialEfficacy outcome
In high-risk localized prostate cancer, additional goserelin did not significantly improve 10-year metastasis-free survival versus short-term treatment.
In plain wordsIn high-risk localized prostate cancer, additional goserelin did not significantly improve survival without metastases compared with short-term treatment.
Peptide
Goserelin
Outcome
No significant changeHigh-risk 10-year metastasis-free survival
Study
n: not reported in source
Comparator
Short-term androgen deprivation with high-dose radiotherapy
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · subcutaneous · 24 additional monthsAs given in this study (human).
Measurements
Survival
76.6%
LTAD at 10 years
Survival
65%
STAD at 10 years
Hazard ratio
0.89
95% CI 0.33-2.43
P
0.82
comparison
Source sentences
Summary
and the 10-year metastasis-free survival was 76·6% (95% CI 67·6-85·6) for LTAD and 65·0% (55·1-74·8) for STAD (HR 0·89; 95% CI 0·33-2·43; p=0·82).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients were randomly assigned (1:1) to receive 4 months of neoadjuvant and concomitant short-term androgen deprivation (STAD) plus high-dose radiotherapy (minimum dose 76 Gy; median dose 78 Gy) or to receive the same treatment followed by 24 months of adjuvant long-term androgen deprivation (LTAD),
Summary · context
Patients assigned to LTAD continued with goserelin every 3 months for another 24 months.
Report a problemFND-3542746906

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

RecruitingPhase 3NCT05781217

Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624

Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápicn = 53414 Mar 2023 to est. Dec 2032

Prostate Cancer · Salvage Radiotherapy · Biochemical Recurrence · Androgen Deprivation Therapy · Metastases-free Survival

Trial page ClinicalTrials.govUpdated 18 Nov 2023

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

Subjects

Terms as the source lists them.

Publication types

MeSH terms

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