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

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ClinicalTrials.gov Identifier: NCT03238066
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Vratislav Strnad, University of Erlangen-Nürnberg Medical School

Study Description
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Brief Summary:
Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Brachytherapy Other: Hyperthermia Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of late GI/GU grade 3 and more toxicities [ Time Frame: up to 60 Months in Follow up ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238066


Contacts
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Contact: Vratislav Strnad, MD ++49(0)9131-85 ext 33419 vratislav.strnad@uk-erlangen.de
Contact: Studiensekretariat ++49(0)9131-85 ext 33968 st-studiensekretariat@uk-erlangen.de

Locations
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Germany
Strahlenklinik im Universitaetsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Vratislav Strnad, MD    ++49(0)9131-85 ext 33419    vratislav.strnad@uk-erlangen.de   
Poland
Centrum Radiotherapii Recruiting
Kraków, Poland, 31-826
Contact: Andrzej Kukielka, MD         
Maria Sklodowska-Curie Institute - Oncology Center Recruiting
Warszaw, Poland, 02-034
Contact: Mateusz Dabkowski, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Vratislav Strnad, MD Assistant Medical Director of the Dept. of Radiooncology
More Information
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Responsible Party: Vratislav Strnad, Assistant Medical Director of the Dept. of Radiooncology, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03238066    
Other Study ID Numbers: Prostata-BT-HT
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Prostatic Neoplasms
Fever
Neoplasms
Genital Neoplasms, Male
 Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Body Temperature Changes