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

NCT ID: NCT03238066

Last Updated: 2018-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2022-04-30

Brief Summary

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

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

The physician can choose either HDR or PDR brachytherapy.

If HDR BT is chosen:

d1: hyperthermia (IHT) 60 minutes + 10Gy HDR brachytherapy (HDRBT) d22: IHT 60 minutes + 10 Gy HDRBT d43: IHT 60 minutes + 10 Gy HDRBT

If PDR BT is chosen:

d1-3: IHT 60 minutes + 30Gy PDRBT d29-31: IHT 60 minutes + 30Gy PDRBT

Group Type: EXPERIMENTAL

Brachytherapy

Intervention Type: RADIATION

HDR/PDR brachytherapy

Hyperthermia

Intervention Type: OTHER

Interstitial hyperthermia

Interventions

Brachytherapy

HDR/PDR brachytherapy

Intervention Type: RADIATION

Hyperthermia

Interstitial hyperthermia

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Vratislav Strnad

Assistant Medical Director of the Dept. of Radiooncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vratislav Strnad, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Medical Director of the Dept. of Radiooncology

Locations

Strahlenklinik im Universitaetsklinikum Erlangen

Erlangen, , Germany

Site Status: RECRUITING

Centrum Radiotherapii

Krakow, , Poland

Site Status: RECRUITING

Maria Sklodowska-Curie Institute - Oncology Center

Warsaw, , Poland

Site Status: RECRUITING

Countries

Germany; Poland

Central Contacts

Vratislav Strnad, MD

Role: CONTACT

vratislav.strnad@uk-erlangen.de

++49(0)9131-85 ext. 33419

Studiensekretariat

Role: CONTACT

st-studiensekretariat@uk-erlangen.de

++49(0)9131-85 ext. 33968

Facility Contacts

Vratislav Strnad, MD

Role: primary

vratislav.strnad@uk-erlangen.de

++49(0)9131-85 ext. 33419

Andrzej Kukielka, MD

Role: primary

Mateusz Dabkowski, MD

Role: primary

Other Identifiers

Prostata-BT-HT

Identifier Type: -

Identifier Source: org_study_id