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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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There is an increasing number of reports describing the existence of a proportion of prostate cancer patients who present with a reduced number of metastases (<5 lesions) at relapse. This oligometastatic status has also been recognized in other tumor types such as melanoma, soft tissue sarcoma, liver, lung, and breast cancer, and has influenced the management of these malignancies in that a more radical treatment such as surgical resection has been employed. Positron Emission Tomography-Computed Tomography (PET-CT) studies with tracers such as choline or acetate are reliable tools to help with the diagnosis of oligometastatic disease after biochemical treatment failure in prostate cancer. An aggressive treatment combining androgen depriving therapy (ADT) and and high-dose irradiation to the oligometastatic lesions, as detected by PET-CT, may be proposed for these oligometastatic patients. Such a treatment strategy may hypothetically succeed to prolong the failure-free interval between two consecutive ADT courses, or even cure selected patients with limited metastatic burden. In this study the investigators plan to assess biochemical or clinical relapse-free survival at 2 years of prostate cancer with 1-5 oligometastases treated concomitantly with high-dose conformal Radiation Therapy and LH-RH agonists.
Hormonotherapy
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.
Radiotherapy
Conformational Radiotherapy techniques in Intensity-Modulated (IMRT)
2.1) Doses prescribed
2.2) Treatment
Radiation Guided by a picture (IGRT) will be performed daily. This daily recalibration will be based at least on bone structures. It will be possible to readjust the nodal structures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hight dose IMRT, ELIGARD | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELIGARD | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Relapse-Free Survival Time (Biochemical or Clinical) | 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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SUPIOT Stéphane, MD | Institut de Cancérologie de l'Ouest (ICO) - Nantes, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICO Paul Papin | Angers | France | ||||
| ICO René Gauducheau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26408012 | Derived | Supiot S, Rio E, Pacteau V, Mauboussin MH, Campion L, Pein F. OLIGOPELVIS - GETUG P07: a multicentre phase II trial of combined salvage radiotherapy and hormone therapy in oligometastatic pelvic node relapses of prostate cancer. BMC Cancer. 2015 Sep 25;15:646. doi: 10.1186/s12885-015-1579-0. | |
| 25963190 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hight Dose IMRT, ELIGARD |
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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hight Dose IMRT, ELIGARD |
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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Relapse-Free Survival Time (Biochemical or Clinical) | 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. | Posted | Median | 95% Confidence Interval | months | 2 years |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hight Dose IMRT, ELIGARD |
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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recto-sigmoid junction stenosis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| genito-urinary | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | 2 year-grade 2+ genito urinary toxicity |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Stéphane SUPIOT | Institut de Cancérologie de l'Ouest | 2 40 67 99 00 | +33 | stephane.supiot@ico.unicancer.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2022 | Jan 27, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C493311 | luprolide acetate gel depot |
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|
|
| Saint-Herblain |
| 44800 |
| France |
| Ploussard G, Almeras C, Briganti A, Giannarini G, Hennequin C, Ost P, Renard-Penna R, Salin A, Lebret T, Villers A, Soulie M, de la Taille A, Flamand V. Management of Node Only Recurrence after Primary Local Treatment for Prostate Cancer: A Systematic Review of the Literature. J Urol. 2015 Oct;194(4):983-8. doi: 10.1016/j.juro.2015.04.103. Epub 2015 May 9. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 1 |
| 67 |
| 5 |
| 67 |
| 5 |
| 67 |
| post radiation proctatis | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| sylvian stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| urinary retention | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| incontinence | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |