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

NCT03238066 | Unknown

• 1 other identifier: Prostata-BT-HT
• Study Type: interventional
• Target: 77
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of late GI/GU grade 3 and more toxicities

  up to 60 Months in Follow up

Secondary Outcomes (6)

• Rate of acute GI/GU treatment-related adverse events

  up to 24 months after start of recruitment

• Time to biochemical failure

  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

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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; Other: Hyperthermia

Interventions

Brachytherapy RADIATION

HDR/PDR brachytherapy

Treatment Arm

Hyperthermia OTHER

Interstitial hyperthermia

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (3)

Strahlenklinik im Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

Centrum Radiotherapii

Krakow, 31-826, Poland

RECRUITING

Maria Sklodowska-Curie Institute - Oncology Center

Warsaw, 02-034, Poland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy; Diathermy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Hyperthermia, Induced

Study Officials

• Vratislav Strnad, MD

  Assistant Medical Director of the Dept. of Radiooncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vratislav Strnad, MD

CONTACT

++49(0)9131-85; vratislav.strnad@uk-erlangen.de

Studiensekretariat

CONTACT

++49(0)9131-85; st-studiensekretariat@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Medical Director of the Dept. of Radiooncology

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: August 3, 2017
• Study Start: April 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2022
• Last Updated: June 7, 2018

Record last verified: 2018-06

Locations

DE (1); PL (2)