JOURNAL ONKOLOGIE – STUDIE
Prostata-BT-HT
Vratislav Strnad, MD
Principal Investigator
Assistant Medical Director of the Dept. of Radiooncology
Vratislav Strnad, MD
Kontakt:
Phone: ++49(0)9131-85
Phone (ext.): 33419
E-Mail: vratislav.strnad@uk-erlangen.de» Kontaktdaten anzeigen
Studiensekretariat
Kontakt:
Phone: ++49(0)9131-85
Phone (ext.): 33968
E-Mail: st-studiensekretariat@uk-erlangen.de» Kontaktdaten anzeigen
Studienlocations
Strahlenklinik im Universitaetsklinikum Erlangen
91054 Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Vratislav Strnad, MD
Phone: ++49(0)9131-85
Phone (ext.): 33419
E-Mail: vratislav.strnad@uk-erlangen.de» Ansprechpartner anzeigen Centrum Radiotherapii
31-826 Kraków
PolandRekrutierend» Google-Maps
Ansprechpartner:
Andrzej Kukielka, MD» Ansprechpartner anzeigen Maria Sklodowska-Curie Institute - Oncology Center
02-034 Warszaw
PolandRekrutierend» Google-Maps
Ansprechpartner:
Mateusz Dabkowski, MD» Ansprechpartner anzeigen
Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy:
Salvage brachytherapy: HDRBT: 3 x 10 Gy specified on prostate capsule/tumor margin (d1, 22, 43) or PDRBT: 2 x 30 Gy specified on prostate capsule/tumor margin (d1-3, 29-31) Hyperthermia: prostate heated to 40 - 47˚C for 30-60 minutes (60 minutes recommended) prior to brachytherapy dose delivery. Maximum temperature in surrounding critical normal organs should not exceed 43˚C
- Histologically-confirmed locally recurrent prostate cancer - biopsy performed < 6 months before registration;
- Histology: Adenocarcinoma, every Gleason score (2-10)
- Initial treatment (EBRT) completed > 24 months prior to biopsy;
- Androgen deprivation therapy for prostate cancer should be discontinued at least 3 months prior to patient registration
- Staging performed within 12 weeks prior to registration:
- Local stage evaluated by DRE, TRUS or - if necessary - mpMRI (T1b, T1c, T2a, T2b, T2c, T3a, T3b);
- Negative lymph nodes by imaging studies (at least one of these: choline PET scan, pelvic ± abdominal CT or MRI) or by lymphadenectomy (cN0 or pN0);
- Negative bone scan (M0);
- PSA-DT > 6 months (PSA measurements taken of the 12 months prior to registration)
- Zubrod Performance Scale 0-2 (Appendix V) International Prostate Symptoms Score (IPSS) < 20 (Appendix VI), the IPSS score can be evaluated in patient on alpha-blockers;
- Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade 0-1 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
In TRUS volume study performed 0-4 weeks before registration patient meets eligibility criteria for prostate brachytherapy as follows:
- Prostate/tumor volume <60ml
- The distance rear prostate edge - rectal mucosa >5mm
- Interference of pubic arch ruled out
- If local stage T3b: it must be possible to cover by the brachytherapy dose cancer infiltration
- Prostate lenght (from apex plane to base plane) ≤ 45mm (technical criterion for 915 MHz frequency antennas)
- The patient is suitable for spinal or general anesthesia
- Age > 18 y.
- Life expectancy > 5 years
- absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- The patient must sign a study-specific informed consent form before study registration
Exclusion Criteria:
- Severe, active comorbidities:
- Decompensated congestive heart disease
- Chronic obstructive pulmonary disease exacerbation, respiratory failure
- Hepatic insufficiency resulting in coagulation defects or clinical jaundice
- Other active malignancy or treatment of invasive or hematological malignancy
- Evidence of extraprostatic disease at local recurrence:
- Local stage T4
- Histologic or radiologic evidence of lymph node metastases (N1 or pN1)
- Presence of distant metastases (M1)
- Any of the following prior therapies:
- TURP within 6 months prior to registration
- Prostatic salvage cryosurgery performed at least 6 months before registration
- HIFU performed at least 6 months before registration
- Androgen deprivation therapy within 3 months prior to registration
- Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade ≥ 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
1. Rate of late GI/GU grade 3 and more toxicities (Time Frame - up to 60 Months in Follow up)
Secondary outcome:
1. Rate of acute GI/GU treatment-related adverse events (Time Frame - up to 24 months after start of recruitment)
2. Time to biochemical failure (Time Frame - up to 60 Months in Follow up):
defined rise of PSA
3. Overall survival (Time Frame - up to 60 Months in Follow up)
4. Disease-free survival (Time Frame - up to 60 Months in Follow up)
5. Disease-specific survival (Time Frame - up to 60 Months in Follow up)
6. Clinical patterns of tumor recurrence (Time Frame - up to 60 Months in Follow up)
Salvage Brachytherapy and Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following Radiation Therapy
Rekrutierend
NCT-Nummer:
NCT03238066
Studienbeginn:
April 2015
Letztes Update:
07.06.2018
Wirkstoff:
-
Indikation (Clinical Trials):
Prostatic Neoplasms, Fever
Geschlecht:
Männer
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborator:
-
Studienleiter
Principal Investigator
Assistant Medical Director of the Dept. of Radiooncology
Kontakt
Kontakt:
Phone: ++49(0)9131-85
Phone (ext.): 33419
E-Mail: vratislav.strnad@uk-erlangen.de» Kontaktdaten anzeigen
Kontakt:
Phone: ++49(0)9131-85
Phone (ext.): 33968
E-Mail: st-studiensekretariat@uk-erlangen.de» Kontaktdaten anzeigen
Studienlocations
(3 von 3)
91054 Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Vratislav Strnad, MD
Phone: ++49(0)9131-85
Phone (ext.): 33419
E-Mail: vratislav.strnad@uk-erlangen.de» Ansprechpartner anzeigen
31-826 Kraków
PolandRekrutierend» Google-Maps
Ansprechpartner:
Andrzej Kukielka, MD» Ansprechpartner anzeigen
02-034 Warszaw
PolandRekrutierend» Google-Maps
Ansprechpartner:
Mateusz Dabkowski, MD» Ansprechpartner anzeigen
Studien-Informationen
Detailed Description:Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy:
Salvage brachytherapy: HDRBT: 3 x 10 Gy specified on prostate capsule/tumor margin (d1, 22, 43) or PDRBT: 2 x 30 Gy specified on prostate capsule/tumor margin (d1-3, 29-31) Hyperthermia: prostate heated to 40 - 47˚C for 30-60 minutes (60 minutes recommended) prior to brachytherapy dose delivery. Maximum temperature in surrounding critical normal organs should not exceed 43˚C
Ein-/Ausschlusskriterien
Inclusion Criteria:- Histologically-confirmed locally recurrent prostate cancer - biopsy performed < 6 months before registration;
- Histology: Adenocarcinoma, every Gleason score (2-10)
- Initial treatment (EBRT) completed > 24 months prior to biopsy;
- Androgen deprivation therapy for prostate cancer should be discontinued at least 3 months prior to patient registration
- Staging performed within 12 weeks prior to registration:
- Local stage evaluated by DRE, TRUS or - if necessary - mpMRI (T1b, T1c, T2a, T2b, T2c, T3a, T3b);
- Negative lymph nodes by imaging studies (at least one of these: choline PET scan, pelvic ± abdominal CT or MRI) or by lymphadenectomy (cN0 or pN0);
- Negative bone scan (M0);
- PSA-DT > 6 months (PSA measurements taken of the 12 months prior to registration)
- Zubrod Performance Scale 0-2 (Appendix V) International Prostate Symptoms Score (IPSS) < 20 (Appendix VI), the IPSS score can be evaluated in patient on alpha-blockers;
- Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade 0-1 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
In TRUS volume study performed 0-4 weeks before registration patient meets eligibility criteria for prostate brachytherapy as follows:
- Prostate/tumor volume <60ml
- The distance rear prostate edge - rectal mucosa >5mm
- Interference of pubic arch ruled out
- If local stage T3b: it must be possible to cover by the brachytherapy dose cancer infiltration
- Prostate lenght (from apex plane to base plane) ≤ 45mm (technical criterion for 915 MHz frequency antennas)
- The patient is suitable for spinal or general anesthesia
- Age > 18 y.
- Life expectancy > 5 years
- absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- The patient must sign a study-specific informed consent form before study registration
Exclusion Criteria:
- Severe, active comorbidities:
- Decompensated congestive heart disease
- Chronic obstructive pulmonary disease exacerbation, respiratory failure
- Hepatic insufficiency resulting in coagulation defects or clinical jaundice
- Other active malignancy or treatment of invasive or hematological malignancy
- Evidence of extraprostatic disease at local recurrence:
- Local stage T4
- Histologic or radiologic evidence of lymph node metastases (N1 or pN1)
- Presence of distant metastases (M1)
- Any of the following prior therapies:
- TURP within 6 months prior to registration
- Prostatic salvage cryosurgery performed at least 6 months before registration
- HIFU performed at least 6 months before registration
- Androgen deprivation therapy within 3 months prior to registration
- Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade ≥ 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Studien-Rationale
Primary outcome:1. Rate of late GI/GU grade 3 and more toxicities (Time Frame - up to 60 Months in Follow up)
Secondary outcome:
1. Rate of acute GI/GU treatment-related adverse events (Time Frame - up to 24 months after start of recruitment)
2. Time to biochemical failure (Time Frame - up to 60 Months in Follow up):
defined rise of PSA
3. Overall survival (Time Frame - up to 60 Months in Follow up)
4. Disease-free survival (Time Frame - up to 60 Months in Follow up)
5. Disease-specific survival (Time Frame - up to 60 Months in Follow up)
6. Clinical patterns of tumor recurrence (Time Frame - up to 60 Months in Follow up)
Geprüfte Regime
- Brachytherapy:
HDR/PDR brachytherapy - Hyperthermia:
Interstitial hyperthermia
Quelle: ClinicalTrials.gov
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