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NCT01368588 | SNCTP000002797

Untersuchung einer verkürzten Strahlentherapie im Vergleich zur Strahlentherapie mit Standarddauer bei Postatakarzinom

Datenbasis: BASEC (Import vom 10.12.2018), WHO (Import vom 09.12.2018)
Geändert: 02.11.2018
Krankheitskategorie: Chirurgie, Prostatakrebs

Zusammenfassende Beschreibung der Studie (Datenquelle: BASEC)

Das Prostatakarzinom ist der häufigste bösartige Tumor des Mannes und die kumulative Inzidenz wird aufgrund der demographischen Entwicklung bis 2030 noch steigen.
Bei 65-70-jährigen Patienten wird in etwa 2/3 der Fälle die radikale Prostatektomie vorgenommen. In fortgeschrittenen Stadien erfolgt heute bei etwa 20% der Patienten eine sofortige postoperative (=adjuvante) bzw. verzögerte (=salvage) Radiotherapie im Bereich der Prostataloge mit 6400-7000 cGy über 6-8 Wochen (NCCN, S3-Richtlinen, bzw. Anhang 1). Dieser Prozentsatz wird wegen verbessertem präoperativem Staging vermutlich abnehmen, wobei wegen steigender Fallzahlen die Radiotherapiefrequenz hingegen hoch bleiben wird. Die Studie wird die Nebenwirkungen einer verkürzten Strahlentherapie mit einer höheren täglichen Dosis mit denjenigen einer konventionellen Strahlentherapie vergleichen.

Untersuchte Krankheiten (Datenquelle: BASEC)

Prostatakarzinom

Health conditions (Datenquelle: WHO)

Prostate Cancer

Seltene Krankheit (Datenquelle: BASEC)

Nein

Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne) (Datenquelle: BASEC)

Die Studie wird die Nebenwirkungen einer verkürzten Strahlentherapie mit einer höheren Dosis mit denjenigen einer konventionellen Strahlentherapie vergleichen und ausserdem untersuchen, wie gut der Krebs mit den beiden Therapien kontrolliert werden kann. Dieses Vorgehen soll der Wissenschaft Erkenntnisse darüber vermitteln, ob die Studientherapie gleich oder schlechter ist als die konventionelle Therapie. Die Studientherapie wird in dieser Studie als experimentelle Therapie betrachtet.

Interventions (Datenquelle: WHO)

Radiation: radiation therapy;Radiation: Whole-pelvic radiotherapy (WPRT)

Kriterien zur Teilnahme an der Studie (Datenquelle: BASEC)

Jede Technik der radikalen Prostatektomie erlaubt
- Postoperative Stadien: pT2 (R1) oder pT3 (R0 oder R1)
- Lymphknotenstatus: pN0 oder
- MRI/CT-Becken (<4 Monate alt): LK ≤ 1cm gross
- Ausschluss ossärer Metastasen Skelettszintigraphie, PET-CT <3 Monate alt)
- PSA postoperativ <2.0ng/ml, <30 Tage alt
- Normaler klinischer Untersuchungsbefund
- Guter AEZ (Zubrod 0-1)
- Bereitschaft und Fähigkeit den EPIC-Fragebogen in englischer oder französischer Sprache zu lesen und auszufüllen

Ausschlusskriterien (Datenquelle: BASEC)

- Postoperativer PSA-Nadir >0.2ng/ml und Gleason-score ≥7
- Stadium pT2 (R0), PSA <0.1ng/ml
- Androgen-Suppressionstherapie >6 Monate vor Prostatektomie
- Postoperative Androgen-Suppressionstherapie > 6 Wochen vor Registrierung
- Neoadjuvante Chemotherapie
- Frühere Malignome (Ausnahme: Plattenepithel-Ca der Haut >3 Jahre kontrolliert)
- Vorbestrahlungen im Beckenbereich
- Patient mit instabiler Herzkreislaufsituation, Herzinfarkt <6 Monaten, Nieren-transplantation, akuten Infektionskrankheiten, Hepatitis Child-Pugh B oder C sowie HIV-Patient mit CD4 <200 Zellen/Mikroliter

Inclusion/Exclusion Criteria (Datenquelle: WHO)


DISEASE CHARACTERISTICS:

- Pathologically (histologically or cytologically) proven diagnosis of prostatic
adenocarcinoma within 180 days of registration at moderate- to high-risk for
recurrence as determined by one of the following combinations:

- Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50
ng/mL (includes intermediate- and high-risk patients)

- Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/mL OR

- Gleason score 6 + >= 50% (positive) biopsies + PSA < 50 ng/ml

- Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL Patients previously
diagnosed with low risk prostate cancer undergoing active surveillance who are
re-biopsied and found to have unfavorable intermediate risk disease or favorable
high risk disease according to the protocol criteria are eligible for enrollment
within 180 days of the repeat biopsy procedure.

- History and/or physical examination (to include at a minimum digital rectal
examination of the prostate and examination of the skeletal system and abdomen) within
90 days prior to registration

- Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT
or MR), (but not by nodal sampling, or dissection) within 90 days prior to
registration

- Patients with lymph nodes equivocal or questionable by imaging are eligible if
the nodes are = 1.5 cm

- Patients status post a negative lymph node dissection are not eligible

- No evidence of bone metastases (M0) on bone scan within 120 days prior to registration
(Na F PET/CT is an acceptable substitute)

- Equivocal bone scan findings are allowed if plain films (or CT or MRI) are
negative for metastasis

- Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott,
Hybritech) within 120 days prior to registration

- Study entry PSA should not be obtained during the following time frames:

- Ten-day period following prostate biopsy

- Following initiation of hormonal therapy

- Within 30 days after discontinuation of finasteride

- Within 90 days after discontinuation of dutasteride

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Absolute neutrophil count (ANC) = 1,500/mm³

- Platelet count = 100,000/mm³

- Hemoglobin (Hgb) = 8.0 g/dL (transfusion or other intervention to achieve Hgb = 8.0
g/dL is acceptable)

- No prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for
a minimum of 3 years (1,095 days) and not in the pelvis

- E.g., carcinoma in situ of the oral cavity is permissible; however, patients with
prior history of bladder cancer are not allowed

- No prior hematological (e.g., leukemia, lymphoma, or myeloma) malignancy

- No previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

- No previous pelvic irradiation, prostate brachytherapy or bilateral orchiectomy

- No previous hormonal therapy, such as LHRH agonists (e.g., leuprolide, goserelin,
buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens
(e.g., flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., DES), or
surgical castration (orchiectomy)

- Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset
of androgen ablation (both LHRH agonist and oral anti-androgen) is = 45 days prior to
the date of registration.

- No severe, active co-morbidity, defined as any of the following:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of registration

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
or severe liver dysfunction

- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
Control (CDC) definition

- Protocol-specific requirements may also exclude immuno-compromised patients

- HIV testing is not required for entry into this protocol

- No patients who are sexually active and not willing/able to use medically acceptable
forms of contraception

- No prior allergic reaction to the hormones involved in this protocol

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer

- No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

- No prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH)
agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist
(e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone
acetate), estrogens (e.g., diethylstilbestrol (DES) ), or surgical castration
(orchiectomy)

- No prior pharmacologic androgen ablation for prostate cancer unless the onset of
androgen ablation is = 45 days prior to the date of registration

- No finasteride within 30 days prior to registration

- No dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration

- No prior or concurrent cytotoxic chemotherapy for prostate cancer

- Prior chemotherapy for a different cancer is allowable

- No prior radiotherapy, including brachytherapy, to the region of the study cancer that
would result in overlap of radiation therapy fields

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT01368588

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT01368588

Weitere Informationen zur Studie

Registrationsdatum der Studie

07.06.2011

Einschluss der ersten teilnehmenden Person

01.07.2011

Rekrutierungsstatus

Recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial

Studientyp (Datenquelle: WHO)

Interventional

Design der Studie (Datenquelle: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Datenquelle: WHO)

Phase 3

Primäre Endpunkte (Datenquelle: WHO)

Overall Survival

Sekundäre Endpunkte (Datenquelle: WHO)

Cause-specific survival;Distant metastasis-free survival;Biochemical failure by the Phoenix definition (PSA = 2 ng/mL over the nadir PSA);Incidence of acute adverse events as assessed by the Common Toxicity Criteria for Adverse Effects (CTCAE) current version;Time to late grade 3+ adverse events as assessed by CTCAE current version;Prostate cancer-specific HRQOL change as measured by the EPIC-26 (bowel or urinary domain);Fatigue status as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue-domain change score

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Studiendurchführungsorte

Durchführungsorte in der Schweiz (Datenquelle: BASEC)

Aarau

Durchführungsländer (Datenquelle: WHO)

Canada, Hong Kong, Israel, Singapore, Switzerland, United States

Kontakt für weitere Auskünfte zur Studie

Angaben zur Kontaktperson in der Schweiz (Datenquelle: BASEC)

Dr. med. Stephan Bodis
0041 62 838 5371
Stephan.Bodis@ksa.ch

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Mack Roach, MD
University of California, San Francisco

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Mack Roach, MD
University of California, San Francisco

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

Radiation Therapy Oncology Group

Weitere Sponsoren (Datenquelle : WHO)

National Cancer Institute (NCI)

Weitere Studienidentifikationsnummern

BASEC ID (Datenquelle: BASEC)

2017-02277

Secondary ID (Datenquelle: WHO)

CDR0000701128;NCI-2011-02674