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| ID | Type | Description | Link |
|---|---|---|---|
| AFU-GETUG P15 | Other Identifier | AFU GETUG |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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Randomized non-comparative phase II trial to assess the preliminary signs of antitumor activity of darolutamide plus radiation therapy in patients with unfavorable intermediate risk prostate cancer.
Multicentric randomized non-comparative, open-label, phase II trial, based on signle-stage design, to assess the preliminary signs of antitumor activity of darolutamide plus radiation therapy in patients with unfavorable intermediate risk prostate cancer.
Patients satisfying eligibility criteria will be randomized according to 2 treatment modalities
Two patients randomized in arm A for one patient randomized in arm B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm A: combination of radiotherapy and darolutamide | Experimental | Patients with unfavorable intermediate risk prostate cancer will be treated with darolutamide for a maximum of 6 months combined with external beam radiotherapy |
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| Standard Arm B: combination of radiotherapy and androgen deprivation therapy | Other | Patients with unfavorable intermediate risk prostate cancer will be treated with androgen deprivation therapy (ADT) as per market authorization combined with external beam radiotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Association of darolutamide and EBRT | Drug | Darolutamide will be taken orally at a fixed dose of 600 mg twice daily (1200 mg), on a continuous basis, for a maximum of 6 months. Darolutamide will start at Day 1. - External Beam Radiotherapy (EBRT) will start two months after treatment initiation. All patients will be treated with standard schedules:
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of efficacy in terms of 6-month biological response | Biological response is defined as a PSA concentration <=0.1ng/mL according to Phoenix's criteria | 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of efficacy in terms of biological response at the end of darolutamide or ADT | Biological response is defined as a PSA concentration <=0.1ng/mL according to Phoenix's criteria | An expected average of 6 months |
| 2-month biological response |
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Inclusion Criteria:
Age ≥ 18,
Histological diagnosis of prostate malignancy cancer
Cancer without loco-regional or distant metastasis (tumor assessment must comprise at least Pelvic MRI AND thoraco-abdomino-pelvic contrast-enhanced CT-Scan AND Bone Scintigraphy. (Note that additional assessment by PET-Scan is allowed as per investigator judgement),
Unfavorable intermediate risk prostate cancer diagnosis defined by the NCCN Guidelines.
One of the following criteria is sufficient to define an unfavorable intermediate risk prostate cancer:
If these criteria are not being identified, two or three of the following criteria are necessary to define unfavorable intermediate risk prostate cancer:
Patients newly diagnosed with an unfavorable intermediate risk prostate cancer according to the protocol criteria or previously diagnosed with low risk (Gleason score < 6, clinical stage < T2a, and PSA< 10) prostate cancer progressing to eligible risk disease according to the protocol criteria within 30 days before registration
Patients must have a life expectancy of at least 5 years,
Performance status ECOG ≤ 2,
Patients without contra-indications to EBRT as per physician judgement,
Patients with adequate organ function defined by all the following laboratory values
Available archived paraffin-embedded tumor sample for research purpose,
Patients with a social security in compliance with the french law,
Voluntary signed and dated written informed consent prior to any study specific procedure,
Men must agree to use an effective method of contraception throughout the treatment period and for one week after discontinuation of treatment.
Exclusion Criteria:
Male patients with prostate cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul SARGOS, MD | Contact | +33556333333 | p.sargos@bordeaux.unicancer.fr | |
| Simone MATHOULIN-PELISSIER, MD, PhD | Contact | s.mathoulin@bordeaux.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sainte Catherine, Institut du Cancer Avignon-Provence | Not yet recruiting | Avignon | 84918 | France |
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| Association of ADT and EBRT | Drug | Treatment by Androgen Deprivation Therapy (ADT) will be prescribed as per market authorization and following investigator judgement. ADT treatment will consist on:
External Beam Radiotherapy (EBRT) will start two months after treatment initiation. All patients will be treated by high dose irradiation in stereotactic conditions:
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Biological response is defined as a PSA concentration <=0.1ng/mL according to Phoenix's criteria
| 2 months after randomization |
| 3-month biological response | Biological response is defined as a PSA concentration <=0.1ng/mL according to Phoenix's criteria | 3 months after the end of radiotherapy |
| 6-month biological response | Biological response is defined as a PSA concentration <=0.1ng/mL according to Phoenix's criteria | 6 months after the end of radiotherapy |
| 9-month biological response | Biological response is defined as a PSA concentration <=0.1ng/mL according to Phoenix's criteria | 9 months after the end of radiotherapy |
| 2-year biological response | Biological response is defined as a PSA concentration <=0.1ng/mL according to Phoenix's criteria | 2 years after randomization |
| 3-year biological response | Biological response is defined as a PSA concentration <=0.1ng/mL according to Phoenix's criteria | 3 years after randomization |
| 5-year biological response | Biological response is defined as a PSA concentration <=0.1ng/mL according to Phoenix's criteria | 5 years after randomization |
| 2-year biochemical progression-free survival (bPFS) | Biochemical progression-free survival is defined as the delay between the date of randomization and the date of biochemical disease progression or death, whichever comes first. | 2 years |
| 3-year biochemical progression-free survival (bPFS) | Biochemical progression-free survival is defined as the delay between the date of randomization and the date of biochemical disease progression or death, whichever comes first. | 3 years |
| 5-year biochemical progression-free survival (bPFS) | Biochemical progression-free survival is defined as the delay between the date of randomization and the date of biochemical disease progression or death, whichever comes first. | 5 years |
| 2-year metastasis free survival (MFS) | Metastasis free survival is defined as the delay between the date of randomization and the date of metastasis diagnosis (imaging and/or biopsy) | 2 years |
| 3-year metastasis free survival (MFS) | Metastasis free survival is defined as the delay between the date of randomization and the date of metastasis diagnosis (imaging and/or biopsy) | 3 years |
| 5-year metastasis free survival (MFS) | Metastasis free survival is defined as the delay between the date of randomization and the date of metastasis diagnosis (imaging and/or biopsy) | 5 years |
| 2-year disease free survival (DFS) | Disease free survival is defined as the delay between the date of randomization and the first of the following events: biological PSA progression defined as level higher than PSA nadir + 2ng/mL according to Phoenix's criteria ; progression (local, regional, distant) or death (any cause) | 2 years |
| 3-year disease free survival (DFS) | Disease free survival is defined as the delay between the date of randomization and the first of the following events: biological PSA progression defined as level higher than PSA nadir + 2ng/mL according to Phoenix's criteria ; progression (local, regional, distant) or death (any cause) | 3 years |
| 5-year disease free survival (DFS) | Disease free survival is defined as the delay between the date of randomization and the first of the following events: biological PSA progression defined as level higher than PSA nadir + 2ng/mL according to Phoenix's criteria ; progression (local, regional, distant) or death (any cause) | 5 years |
| 2-year prostate cancer-specific survival (PCSS) | Prostate cancer-specific Survival is defined as the delay between the date of randomization and the date of prostate cancer-related death | 2 years |
| 3-year prostate cancer-specific survival (PCSS) | Prostate cancer-specific Survival is defined as the delay between the date of randomization and the date of prostate cancer-related death | 3 years |
| 5-year prostate cancer-specific survival (PCSS) | Prostate cancer-specific Survival is defined as the delay between the date of randomization and the date of prostate cancer-related death | 5 years |
| 2-year overall survival (OS) | Overall survival is defined as the delay between the date of randomization and the date of death (all cause). | 2 years |
| 3-year overall survival (OS) | Overall survival is defined as the delay between the date of randomization and the date of death (all cause). | 3 years |
| 5-year overall survival (OS) | Overall survival is defined as the delay between the date of randomization and the date of death (all cause). | 5 years |
| Time to testosterone recovery | Time to testosterone recovery defined as the time from randomization to the time when serum of total testosterone level increases to above the lower limit of the normal range. | An expected average of 6 months |
| Acute safety profile independently for each treatment strategy | Toxicity graded using the Common Terminology Criteria for Adverse Events version 5 | 3 months |
| Late 2-year safety profile independently for each treatment strategy | Toxicity graded using the Common Terminology Criteria for Adverse Events version 5 | 2 years |
| Late 3-year safety profile independently for each treatment strategy | Toxicity graded using the Common Terminology Criteria for Adverse Events version 5 | 3 years |
| Late 5-year safety profile independently for each treatment strategy | Toxicity graded using the Common Terminology Criteria for Adverse Events version 5 | 5 years |
| Assessment of quality of life | Quality of life will be assessed as per the EORTC QLQ-C30 questionnaire and prostate cancer module PR-25 | Throughout the follow-up period, an expected average of 5 years |
| Assessment of erectile dysfunction | Erectile dysfunction will be assessed as per IIEF5 | Throughout the follow-up period, an expected average of 5 years |
| Assessment of symptoms of benign prostatic hyperplasia | Symptoms of benign prostatic hyperplasia will be assessed as per IPSS | Throughout the follow-up period, an expected average of 5 years |
| CHRU Besançon | Not yet recruiting | Besançon | 25030 | France |
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| Institut Bergonie | Recruiting | Bordeaux | 33076 | France |
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| CHRU Brest - Hôpital Morvan | Not yet recruiting | Brest | 29200 | France |
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| Assitance Publique des Hôpitaux de Marseille - CHU La Timone | Not yet recruiting | Marseille | 13385 | France |
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| Hôpital de la Pitié Salpétrière | Not yet recruiting | Paris | 75651 | France |
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| CHP Saint-Grégoire | Not yet recruiting | Saint-Grégoire | 35760 | France |
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| Institut de Cancérologie de l'Ouest - Site René Gauducheau | Not yet recruiting | Saint-Herblain | 44805 | France |
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| IUCT Oncopôle | Not yet recruiting | Toulouse | 31059 | France |
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| Clinique Pasteur | Not yet recruiting | Toulouse | 31076 | France |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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