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Prostate CancerProstata-BT-HTNCT03238066

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

A study testing Brachytherapy and Hyperthermia in people with Prostate Cancer, run by University of Erlangen-Nürnberg Medical School at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Brachytherapy and Hyperthermia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
3 sitesin 2 countries
Study dates
Apr 2015to Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

3 sites in 2 countries.

Vratislav Strnad, MD contact

++49(0)9131-85 ext. 33419

vratislav.strnad@uk-erlangen.de

Studiensekretariat contact

++49(0)9131-85 ext. 33968

st-studiensekretariat@uk-erlangen.de

3 sites in 2 countries

Poland2 sites, 2 recruiting

  • Centrum Radiotherapii

    Krakow, 31-826

    Andrzej Kukielka, MD

    Recruiting

  • Maria Sklodowska-Curie Institute - Oncology Center

    Warsaw, 02-034

    Mateusz Dabkowski, MD

    Recruiting

Other trials in Poland

Germany1 site, 1 recruiting

  • Strahlenklinik im Universitaetsklinikum Erlangen

    Erlangen, 91054

    Vratislav Strnad, MD, ++49(0)9131-85 ext. 33419, vratislav.strnad@uk-erlangen.de

    Recruiting

Other trials in Germany

About this study

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

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

Read the 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

Conditions
Prostate Cancer
Being tested
Brachytherapy, Hyperthermia
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrachytherapyRadiation

    HDR/PDR brachytherapy

  • HyperthermiaOther

    Interstitial hyperthermia

Study groups in NCT03238066
Study groupRoleWhat they receive
Treatment ArmExperimentalThe 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
Receives: Radiation: Brachytherapy; Other: Hyperthermia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of late GI/GU grade 3 and more toxicities

    Measured: up to 60 Months in Follow up

Secondary outcomes (6)

  1. Rate of acute GI/GU treatment-related adverse events

    Measured: up to 24 months after start of recruitment

  2. Time to biochemical failure

    defined rise of PSA

    Measured: up to 60 Months in Follow up

  3. Overall survival

    Measured: up to 60 Months in Follow up

  4. Disease-free survival

    Measured: up to 60 Months in Follow up

  5. Disease-specific survival

    Measured: up to 60 Months in Follow up

  6. Clinical patterns of tumor recurrence

    Measured: up to 60 Months in Follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2017
  2. Study startApr 2015
  3. Primary completionDec 2018 (estimated)
  4. Study completionApr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
77 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03238066
Sponsor's protocol ID
Prostata-BT-HT
Acronym
Prostata-BT-HT
Status last verified
Jun 2018
First submitted
1 Dec 2015
Last updated
7 Jun 2018
Results posted
No
Data monitoring committee
No

Publications

  • Strnad V, Dabkowski M, Dabrowski T, Brandys P, Kulik A, Gruszczynska E, Ott OJ, Strnad AR, Schmidt M, Lotter M, Kreppner S, Merten R, Fietkau R, Corradini S, Kukielka AM. Prospective Phase 2 Trial: Long-term results of a salvage brachytherapy combined with interstitial hyperthermia as Re-Irradiation for locally recurrent prostate Carcinoma. Radiother Oncol. 2026 May;218:111446. doi: 10.1016/j.radonc.2026.111446. Epub 2026 Feb 15.

    PubMed 41702454

Questions about this trial

What is this clinical trial studying?

A study testing Brachytherapy and Hyperthermia in people with Prostate Cancer, run by University of Erlangen-Nürnberg Medical School at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Poland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vratislav Strnad, MD (++49(0)9131-85 ext. 33419, vratislav.strnad@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of late GI/GU grade 3 and more toxicities (time frame: up to 60 Months in Follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03238066, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2018.

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