Trial Outcomes & Findings for Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer (NCT NCT02274779)
NCT ID: NCT02274779
Last Updated: 2026-02-13
Results Overview
This outcome represents the time from treatment initiation to the occurrence of biochemical or clinical relapse. Relapse is defined as: a PSA level greater than the PSA before treatment, confirmed by two consecutive increases in the same laboratory, and/or an increase in the number of metastatic sites at the evaluation visit. The reported value is the median time to relapse, in months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
2 years
Results posted on
2026-02-13
Participant Flow
Participant milestones
| Measure |
Hight Dose IMRT, ELIGARD
* PTV1 PTV5 to 66 Gy in 30 fractions of 2.2 Gy
* PTV Pelvis: 54 Gy in 30 fractions of 1.8 Gy
* PTV Loge 60 Gy in 30 fractions of 2 Gy 6 Gy A complement of 3 in two additional fractions Gy may be delivered across the lodge PTV.
* PTV Relapse Lodge: In addition to treating the PTV Lodge, additional radiation of 6 Gy in 3 fractions of 2 Gy may be made to bring the total dose of 72 Gy in 36 fractions of 2 Gy.
ELIGARD: Hormone therapy is recommended Eligard 45 mg acting for 6 months. It will be ideally administered the day of start of radiation therapy or within 3 months before the first day of radiotherapy.
Nevertheless, free prescription is left to investigators. When using other hormonal strategies (anti-androgen agonists, LHRH antagonists or LHRH), an administration for six months will be critical.
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
67
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Hight Dose IMRT, ELIGARD
* PTV1 PTV5 to 66 Gy in 30 fractions of 2.2 Gy
* PTV Pelvis: 54 Gy in 30 fractions of 1.8 Gy
* PTV Loge 60 Gy in 30 fractions of 2 Gy 6 Gy A complement of 3 in two additional fractions Gy may be delivered across the lodge PTV.
* PTV Relapse Lodge: In addition to treating the PTV Lodge, additional radiation of 6 Gy in 3 fractions of 2 Gy may be made to bring the total dose of 72 Gy in 36 fractions of 2 Gy.
ELIGARD: Hormone therapy is recommended Eligard 45 mg acting for 6 months. It will be ideally administered the day of start of radiation therapy or within 3 months before the first day of radiotherapy.
Nevertheless, free prescription is left to investigators. When using other hormonal strategies (anti-androgen agonists, LHRH antagonists or LHRH), an administration for six months will be critical.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hight Dose IMRT, ELIGARD
n=67 Participants
* PTV1 PTV5 to 66 Gy in 30 fractions of 2.2 Gy
* PTV Pelvis: 54 Gy in 30 fractions of 1.8 Gy
* PTV Loge 60 Gy in 30 fractions of 2 Gy 6 Gy A complement of 3 in two additional fractions Gy may be delivered across the lodge PTV.
* PTV Relapse Lodge: In addition to treating the PTV Lodge, additional radiation of 6 Gy in 3 fractions of 2 Gy may be made to bring the total dose of 72 Gy in 36 fractions of 2 Gy.
ELIGARD: Hormone therapy is recommended Eligard 45 mg acting for 6 months. It will be ideally administered the day of start of radiation therapy or within 3 months before the first day of radiotherapy.
Nevertheless, free prescription is left to investigators. When using other hormonal strategies (anti-androgen agonists, LHRH antagonists or LHRH), an administration for six months will be critical.
|
|---|---|
|
Age, Continuous
|
68 years
n=67 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=67 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=67 Participants
|
|
Region of Enrollment
France
|
67 Participants
n=67 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThis outcome represents the time from treatment initiation to the occurrence of biochemical or clinical relapse. Relapse is defined as: a PSA level greater than the PSA before treatment, confirmed by two consecutive increases in the same laboratory, and/or an increase in the number of metastatic sites at the evaluation visit. The reported value is the median time to relapse, in months.
Outcome measures
| Measure |
Hight Dose IMRT, ELIGARD
n=67 Participants
* PTV1 PTV5 to 66 Gy in 30 fractions of 2.2 Gy
* PTV Pelvis: 54 Gy in 30 fractions of 1.8 Gy
* PTV Loge 60 Gy in 30 fractions of 2 Gy 6 Gy A complement of 3 in two additional fractions Gy may be delivered across the lodge PTV.
* PTV Relapse Lodge: In addition to treating the PTV Lodge, additional radiation of 6 Gy in 3 fractions of 2 Gy may be made to bring the total dose of 72 Gy in 36 fractions of 2 Gy.
ELIGARD: Hormone therapy is recommended Eligard 45 mg acting for 6 months. It will be ideally administered the day of start of radiation therapy or within 3 months before the first day of radiotherapy.
Nevertheless, free prescription is left to investigators. When using other hormonal strategies (anti-androgen agonists, LHRH antagonists or LHRH), an administration for six months will be critical.
|
|---|---|
|
Median Relapse-Free Survival Time (Biochemical or Clinical)
|
45.3 months
Interval 31.8 to 48.5
|
Adverse Events
Hight Dose IMRT, ELIGARD
Serious events: 5 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Hight Dose IMRT, ELIGARD
n=67 participants at risk
* PTV1 PTV5 to 66 Gy in 30 fractions of 2.2 Gy
* PTV Pelvis: 54 Gy in 30 fractions of 1.8 Gy
* PTV Loge 60 Gy in 30 fractions of 2 Gy 6 Gy A complement of 3 in two additional fractions Gy may be delivered across the lodge PTV.
* PTV Relapse Lodge: In addition to treating the PTV Lodge, additional radiation of 6 Gy in 3 fractions of 2 Gy may be made to bring the total dose of 72 Gy in 36 fractions of 2 Gy.
ELIGARD: Hormone therapy is recommended Eligard 45 mg acting for 6 months. It will be ideally administered the day of start of radiation therapy or within 3 months before the first day of radiotherapy.
Nevertheless, free prescription is left to investigators. When using other hormonal strategies (anti-androgen agonists, LHRH antagonists or LHRH), an administration for six months will be critical.
|
|---|---|
|
Gastrointestinal disorders
Recto-sigmoid junction stenosis
|
1.5%
1/67 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
post radiation proctatis
|
1.5%
1/67 • Number of events 1 • 5 years
|
|
Nervous system disorders
sylvian stroke
|
1.5%
1/67 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
urinary retention
|
1.5%
1/67 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
incontinence
|
1.5%
1/67 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Hight Dose IMRT, ELIGARD
n=67 participants at risk
* PTV1 PTV5 to 66 Gy in 30 fractions of 2.2 Gy
* PTV Pelvis: 54 Gy in 30 fractions of 1.8 Gy
* PTV Loge 60 Gy in 30 fractions of 2 Gy 6 Gy A complement of 3 in two additional fractions Gy may be delivered across the lodge PTV.
* PTV Relapse Lodge: In addition to treating the PTV Lodge, additional radiation of 6 Gy in 3 fractions of 2 Gy may be made to bring the total dose of 72 Gy in 36 fractions of 2 Gy.
ELIGARD: Hormone therapy is recommended Eligard 45 mg acting for 6 months. It will be ideally administered the day of start of radiation therapy or within 3 months before the first day of radiotherapy.
Nevertheless, free prescription is left to investigators. When using other hormonal strategies (anti-androgen agonists, LHRH antagonists or LHRH), an administration for six months will be critical.
|
|---|---|
|
Renal and urinary disorders
genito-urinary
|
7.5%
5/67 • Number of events 5 • 5 years
|
Additional Information
Pr Stéphane SUPIOT
Institut de Cancérologie de l'Ouest
Phone: 2 40 67 99 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60