New combo therapy aims to delay prostate cancer relapse in patients with limited spread
NCT ID NCT02274779
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of high-dose radiation and hormone therapy (leuprorelin) in 74 men with prostate cancer that had returned in up to 5 pelvic lymph nodes after initial treatment. The goal was to see if this approach could delay further cancer growth or relapse. Participants received radiation to the affected nodes plus six months of hormone therapy, and researchers tracked how long it took for the cancer to progress again.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Leuprorelin (Eligard) hormone therapy plus high-dose radiation therapy
- What this could lead to
- If successful, this combination could delay the return of prostate cancer after initial treatment, potentially extending the time before more aggressive therapy is needed.
- What could go wrong
- This is a small, early-phase trial (74 participants) with no control group, so results may not apply broadly. Hormone therapy has side effects like hot flashes and fatigue, and the treatment may not prevent eventual relapse.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
74 people
The number who actually took part.
- Started
-
Aug 2014
- Finished
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Jul 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically proven adenocarcinoma of the prostate 2. Patients aged 18 years or more 3. PS 0-1 4. Previous radical treatment to the prostate (radiotherapy or surgery) 5. PSA increase of at least 3 assays in the same laboratory over the last 12 months. 6. 1-5 pelvic lymph node metastases detected with 18FCH-PET. A relapse in the dressing prostatectomy is associated possible. 7. Upper limit of lymph node metastases: aortic bifurcation 8. Respect dosimetric constraints to organs at risk 9. Treatment with hormone therapy may be started before inclusion, to a maximum of three months prior to Day 1 of radiotherapy. This hormone will necessarily be preceded by a free interval treatment of at least 6 months since the last injection, by adding the duration of action of this predictable injection (1, 3 or 6 months) 10. Patient affiliated to a social security scheme 11. Patient Information and written informed consent form signed Exclusion Criteria: 1. bone or visceral metastatic relapse associated 2. para-aortic nodal relapse (the upper limit is tolerated aortic bifurcation) 3. more than 5 lymph node metastases 4. Proof of metastases at initial diagnosis 5. Evidence of distant metastases in the pelvic lymph nodes or outside the prostate bed 6. prior pelvic lymph nodes Irradiation. Irradiation of the bed of the prostate is not an exclusion criterion, but the junction between prior irradiation bed prostatectomy and radiation field pelvic lymph nodes should be examined carefully 7. castration resistance defined by clinical or biochemical progression despite a combined androgen blockade 8. known contraindications to pelvic irradiation (eg, chronic inflammatory bowel disease, ...) 9. known contraindications to hormone therapy, according to standard recommendations in force 10. serious Hypertension not controlled by appropriate treatment 11. Other concomitant cancer or history of cancer (within 5 years prior to study entry), except basal cell or squamous cell carcinomas of the skin. 12. Patient with a psychological, familial, sociological or geographical potentially hampering compliance with the study protocol and follow-up schedule 13. Patient already included in another interventional study involving the approval of a CPP during his screening for the study OLIGOPELVIS 14. Private person of liberty or major trust
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
ICO Paul Papin
Angers, France
-
ICO René Gauducheau
Saint-Herblain, 44800, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
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- Can a 10-Hour eating window fight cancer fatigue?