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

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 |
- Rate of late GI/GU grade 3 and more toxicities [ Time Frame: up to 60 Months in Follow up ]
- Rate of acute GI/GU treatment-related adverse events [ Time Frame: up to 24 months after start of recruitment ]
- Time to biochemical failure [ Time Frame: up to 60 Months in Follow up ]defined rise of PSA
- Overall survival [ Time Frame: up to 60 Months in Follow up ]
- Disease-free survival [ Time Frame: up to 60 Months in Follow up ]
- Disease-specific survival [ Time Frame: up to 60 Months in Follow up ]
- Clinical patterns of tumor recurrence [ Time Frame: up to 60 Months in Follow up ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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
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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:
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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
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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)
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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.

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
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 |
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 |
Principal Investigator: | Vratislav Strnad, MD | Assistant Medical Director of the Dept. of Radiooncology |
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 |
Prostatic Neoplasms Fever Neoplasms Genital Neoplasms, Male |
Urogenital Neoplasms Neoplasms by Site Prostatic Diseases Body Temperature Changes |