| Titre |
STEEL: A Randomized Phase II Trial of Salvage Radiotherapy With Standard vs Enhanced Androgen Deprivation Therapy (With Enzalutamide) in Patients With Post-Prostatectomy PSA Recurrences With Aggressive Disease Features |
| Protocole ID |
RTOG 3506 |
| ClinicalTrials.gov ID |
NCT03809000 |
| Type(s) de cancer |
Prostate |
| Phase |
Phase II |
| Type étude |
Traitement |
| Médicament |
Radiothérapie + Hormonothérapie vs Radiothérapie + Hormonothérapie + Enzalutamide |
| Institution |
CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
 HOPITAL FLEURIMONT
3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
|
| Ville |
Sherbrooke |
| Investigateur(trice) principal(e) |
Dre Laurence Masson-Côté
|
| Coordonnateur(trice) |
Sophie Couture
819-346-1110 poste 14311
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Pathologically (histologically) proven adenocarcinoma confirmed by prostatectomy performed within 10 years prior to registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted.
- PSA level (≥ 0.7 ng/mL) within 90 days prior to registration. GnRH analog may be started no more than 42 days prior study entry, but patients must have a PSA ≥ 0.7 ng/mL prior to starting ADT.
- Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to registration.
- Platelet count ≥ 75,000 x 109/µL independent of transfusion and/or growth factors within 90 days prior to registration.
- At least 1 of the following aggressive features:
- Gleason score of 8-10 (note any Gleason score is eligible)
- Seminal vesicle invasion (SVI) (note any pT stage [AJCC v8.0] is eligible but a pT stage
- ≥ pT3b is considered aggressive)
- Locoregional node involvement at radical prostatectomy (pN1)
- Persistently elevated PSA post-RP nadir (PEPP) defined as PSA > 0.1 ng/mL after radical prostatectomy
- Serum albumin ≥ 3.0 g/dL within 90 days prior to registration
- GFR >35 mL/min estimated by Cockcroft-Gault or measured directly by 24 hour urine creatinine within 90 days prior to registration.
- Serum total bilirubin ≤1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject is eligible) within 90 days prior to registration.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 × ULN within 90 days prior to registration.
- Testosterone >50 ng/dL within 90 days prior to registration. Prior androgen deprivation (GnRH analog and/or non-steroidal antiandrogen) therapy is allowed provided that serum testosterone concentration must be ≥ 50 ng/dL prior to registration or starting ADT, whichever occurs first; 5-alpha reductase inhibitors will not impact eligibility, but must be discontinued prior to starting protocol treatment.
- History and physical with ECOG Performance Status 0-1 or within 90 days prior to registration.
|
| Critètes d'exclusion |
- Definitive clinical or radiologic evidence of metastatic disease with the exception of locoregional lymph nodes.
- Prior invasive malignancy (except non-melanomatous skin cancer carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years).
- Prior systemic chemotherapy for the study cancer. Note: prior chemotherapy for a different cancer is allowable.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
- History of any of the following:
- Documented inflammatory bowel disease
- Transmural myocardial infarction within the last 4 months prior to registration.
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 4 months prior to registration
- Seizure disorder or condition that may predispose to seizure (e.g. prior cortical stroke or significant brain trauma)
- Uncontrolled hypertension defined as a sustained systolic blood pressure in excess of 150 mmHg or a sustained diastolic blood pressure in excess of 90 mmHg despite optimized antihypertensive therapy.
- Known gastrointestinal disorder affecting absorption of oral medications.
- Active uncontrolled infection defined as an identified infectious condition that requires active therapy that has not yet been completed.
- HIV positive patients with CD4 count < 200 cells/microliter within 30 days prior to registration OR HIV patients under treatment with highly active antiretroviral therapy (HAART) within 30 days prior to registration regardless of CD4 count. Note: HIV testing is not required for eligibility for this protocol as it is self-reported. This exclusion criterion is necessary because the treatments involved in this protocol may be immunosuppressive and/or interact with HAART.
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Groupe d'étude en oncologie du Québec