Salvage Brachytherapy and Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following Radiation Therapy

Prostate Cancer Clinical Trial

— Prostata-BT-HT  

Official title:

A Prospective Phase II Study of Salvage Brachytherapy in Combination With Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following External Beam Radiation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03238066
• Other study ID #: Prostata-BT-HT
• Status: Recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: April 2022

Study information

• Verified date: June 2018
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Vratislav Strnad, MD
• Phone: ++49(0)9131-85
• Email: vratislav.strnad[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77
• Est. completion date: April 2022
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fever
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Brachytherapy
HDR/PDR brachytherapy

Other:
• Hyperthermia
Interstitial hyperthermia

Locations

Country	Name	City	State
Germany	Strahlenklinik im Universitaetsklinikum Erlangen	Erlangen
Poland	Centrum Radiotherapii	Kraków
Poland	Maria Sklodowska-Curie Institute - Oncology Center	Warszaw

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Countries where clinical trial is conducted

Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of late GI/GU grade 3 and more toxicities		up to 60 Months in Follow up
Secondary	Rate of acute GI/GU treatment-related adverse events		up to 24 months after start of recruitment
Secondary	Time to biochemical failure	defined rise of PSA	up to 60 Months in Follow up
Secondary	Overall survival		up to 60 Months in Follow up
Secondary	Disease-free survival		up to 60 Months in Follow up
Secondary	Disease-specific survival		up to 60 Months in Follow up
Secondary	Clinical patterns of tumor recurrence		up to 60 Months in Follow up