Clinical trial NCT03238066: Salvage Brachytherapy and Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following Radiation Therapy
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 77
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Rate of late GI/GU grade 3 and more toxicities
timeFrame: up to 60 Months in Follow up
Secondary outcomes:
measure: Rate of acute GI/GU treatment-related adverse events
timeFrame: up to 24 months after start of recruitment
measure: Time to biochemical failure
timeFrame: up to 60 Months in Follow up
measure: Overall survival
timeFrame: up to 60 Months in Follow up
measure: Disease-free survival
timeFrame: up to 60 Months in Follow up
measure: Disease-specific survival
timeFrame: up to 60 Months in Follow up
measure: Clinical patterns of tumor recurrence
timeFrame: up to 60 Months in Follow up
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Strahlenklinik im Universitaetsklinikum Erlangen
city: Kraków
country: Poland
facility: Centrum Radiotherapii
city: Warszaw
country: Poland
facility: Maria Sklodowska-Curie Institute - Oncology Center
Study officials:
affiliation: Assistant Medical Director of the Dept. of Radiooncology
name: Vratislav Strnad, MD
role: PRINCIPAL_INVESTIGATOR
References: