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NCT04141709Active, not recruiting

Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer

Effektivität Und Toxizität Einer Perkutanen Hochdosierten Strahlentherapie Bei Patienten Mit Oligometastasen Eines Kastrationsresistenten Prostatakarzinoms

Source: ClinicalTrials.gov · Last updated 1 Sept 2026

Brief summary (registry, in English)

The purpose of this randomized trial is to investigate the efficacy and toxicity of percutaneous high-dose radiotherapy in patients with oligometastases of hormone refractory prostate cancer. The effectiveness will be tested in comparison to an observation group, in which no further therapy is initially given. Treatment can be stereotactically hypofractionated or conventionally fractionated.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
66 (estimated)
First submitted
24 Oct 2019
Start date
1 Dec 2019
Primary completion date
28 Apr 2027
Lead sponsor
Technische Universität Dresden
NCT number
NCT04141709

What you commit to

  • Study type: Interventional
  • Planned participants: 66
  • From 1 Dec 2019 to the primary completion date, 28 Apr 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe concomitant disease that limits further life expectancy to \< 5 years according to the physician's assessment.
  • previous taxane-containing chemotherapy

Other

  • PSA \> 20ng/ml, testosterone \>50 dl or \>1,73nmol/l
  • visceral metastasis (e.g. lung, liver, brain)
  • lack of compliance

Who the study is looking for

  • Patient with good general condition (WHO 0-1)
  • Histologically confirmed prostate carcinoma
  • After definitive local therapy, e.g. radical prostatectomy or definitive radiotherapy (also after neo-adjuvant hormone therapy, after postoperative radiotherapy).
  • PSA progression under ongoing androgen deprivation (defined as three consecutive increasing PSA values at intervals of \> 4 weeks and testosterone in the castration area \<50ng/dl or \<1.73nmol/)
  • Minimum duration of androgen deprivation 6 months before inclusion in study
  • Present complete staging (max. 6 weeks old), preferably by means of PET hybrid imaging with prostate-specific PET tracer
  • Imaging detection of individual active or progressive metastases (max. 5, depending on location) that are accessible to local ablative radiotherapy (histological confirmation of the metastases is not required)
  • No parallel participation to further clinical therapy trials up to 4 weeks before and after radiation therapy
  • Individual case discussion in an interdisciplinary tumor board
  • Patient's ability to consent and written consent

Criteria the registry did not label

  • Indication:
  • Oligometastases (1-5) in castration-resistant prostate carcinoma

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden
Coordinator of this site? Confirm its status
DresdenGermanyUnknown status
University Medical Center Freiburg, Department of Radiation Oncology
Coordinator of this site? Confirm its status
Freiburg im BreisgauGermanyUnknown status
University Hospital Heidelberg, Department of Radiation Oncology
Coordinator of this site? Confirm its status
HeidelbergGermanyUnknown status
University Clinic Tübingen, Clinic for Radiation Oncology
Coordinator of this site? Confirm its status
TübingenGermanyUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.