Salvage Brachytherapy and Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following Radiation Therapy (Prostata-BT-HT)

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

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

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Brachytherapy; Other: Hyperthermia

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

• Study Type: Interventional
• Enrollment (Anticipated): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • Recruiting
    • Strahlenklinik im Universitaetsklinikum Erlangen
    • Contact: Vratislav Strnad, MD; Phone Number: 33419 ++49(0)9131-85; Email: vratislav.strnad@uk-erlangen.de
• Poland
  • Kraków, Poland, 31-826
    • Recruiting
    • Centrum Radiotherapii
    • Contact: Andrzej Kukielka, MD
  • Warszaw, Poland, 02-034
    • Recruiting
    • Maria Sklodowska-Curie Institute - Oncology Center
    • Contact: Mateusz Dabkowski, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Radiation: Brachytherapy; HDR/PDR brachytherapy; Other: Hyperthermia; Interstitial hyperthermia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of late GI/GU grade 3 and more toxicities	up to 60 Months in Follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of acute GI/GU treatment-related adverse events		up to 24 months after start of recruitment
Time to biochemical failure	defined rise of PSA	up to 60 Months in Follow up
Overall survival		up to 60 Months in Follow up
Disease-free survival		up to 60 Months in Follow up
Disease-specific survival		up to 60 Months in Follow up
Clinical patterns of tumor recurrence		up to 60 Months in Follow up

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Investigators: Principal Investigator: Vratislav Strnad, MD, Assistant Medical Director of the Dept. of Radiooncology

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): June 7, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Wounds and Injuries; Genital Neoplasms, Male; Prostatic Diseases; Body Temperature Changes; Heat Stress Disorders; Prostatic Neoplasms; Hyperthermia
• Other Study ID Numbers: Prostata-BT-HT