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SNCTP000001737 | NCT01368588

Antihormontherapie kombiniert mit perkutaner Strahlentherapie der Prostata mit/ohne Lymphabflussweg

Datenbasis: BASEC (Import vom 14.06.2024), WHO (Import vom 13.06.2024)
Geändert: 01.09.2023, 01:00
Krankheitskategorie: Prostatakrebs

Zusammenfassende Beschreibung der Studie (Datenquelle: BASEC)

Kombination von Antihormontherapie und Bestrahlung des Prostata und Becken verglichen mit Antihormontherapie und alleinige Bestrahlung der Prostata

Untersuchte Krankheiten(Datenquelle: BASEC)

Die vorliegende Studie soll klären, ob die zusätzliche Bestrahlung der Lymphabflusswege im Vergleich mit Kombination aus hochdosierter Radiotherapie und Antiandrogentherapie für Patienten mit mittlerem und leicht erhöhtem Metastasierungsrisiko einen Ueberlebensvorteil bringt.

Health conditions (Datenquelle: WHO)

Prostate Cancer

Seltene Krankheit (Datenquelle: BASEC)

Nein

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

Alle Patienten erhalten die Antihormontherapie, bestehend aus dem Antiandrogen Bicalutamide (Casodex) in Kombination mit einem LHRH-Antagonisten. Die Verwendung der beiden Medikamente wirkt als kombinierte Androgen-Blockade. Die Behandlung muss innerhalb von 6 Wochen nach der Randomisierung starten. Die Strahlentherapie beginnt 8-10 Wochen nach Start der Androgen-Blockade. Patienten erhalten entweder Bestrahlung der Prostata und Samenblasen und Dosisaufsättigung im Bereich der Prostata und Samenblasenbasis oder Bestrahlung der Prostata, Samenblasen und des Lymphabflusses im kleinen Becken, gefolgt von Dosisaufsättigung im Bereich der Prostata und Samenblasenbasis

Interventions (Datenquelle: WHO)

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

Kriterien zur Teilnahme an der Studie (Datenquelle: BASEC)

Diagnose eines Prostata-Adenokarzinoms mit mässigem bis leicht erhöhtem Risiko für lokoregionäre Lymphknoten Metastasen
Bildgeberisch fehlender Nachweis vom Lymphknoten Metastasen im kleinen Becken

Ausschlusskriterien (Datenquelle: BASEC)

Vorangegangene radikale Operation (Prostatektomie) oder Kryo-Operation wegen Prostatakrebs
Der Patient erkrankte bereits früher an einem invasiven Krebs, nicht im Beckenbereich (Eine Teilnahme ist möglich, wenn er seit mind. 3 Jahre als geheilt gilt)

Inclusion/Exclusion Criteria (Datenquelle: WHO)

Gender: Male
Maximum age: N/A
Minimum age: 18 Years

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/mm?

- Platelet count = 100,000/mm?

- 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/ct2/show/NCT01368588

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

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT01368588
Weitere Informationen zur Studie

Rekrutierungsstatus

Active, not 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;Assessment and comparison of Quality Adjusted Life Years (QALYs)

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Ergebnisse der Studie (Datenquelle: WHO)

Zusammenfassung der Ergebnisse

noch keine Angaben verfügbar

Link zu den Ergebnissen im Primärregister

noch keine Angaben verfügbar

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten

No

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)

Khan Shaka
062-838-5380
shaka.khan@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

Bewilligung durch Ethikkommission (Datenquelle: BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

CDR0000701128
NCI-2011-02674
RTOG-0924
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