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Oligometastatic DiseaseOLI-CR-PNCT04141709

Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer

A study testing local ablative radiotherapy in people with Oligometastatic Disease and Prostatic Cancer, Castration-Resistant, run by Technische Universität Dresden at 4 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
local ablative radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
4 sitesGermany
Study dates
1 Dec 2019to 28 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • Severe concomitant disease that limits further life expectancy to < 5 years according to the physician's assessment.
  • PSA > 20ng/ml, testosterone >50 dl or >1,73nmol/l
  • visceral metastasis (e.g. lung, liver, brain)
  • lack of compliance
  • previous taxane-containing chemotherapy

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden

    Dresden, Saxony, 01307

  • University Medical Center Freiburg, Department of Radiation Oncology

    Freiburg im Breisgau

  • University Hospital Heidelberg, Department of Radiation Oncology

    Heidelberg

  • University Clinic Tübingen, Clinic for Radiation Oncology

    Tübingen

Other trials in Germany

About this study

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

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.

Read the detailed description

This is a multicentric, randomized, prospective Phase II intervention trial. Efficacy is measured as the rate in patients with PSA progression one year after randomization (defined as PSA nadir after randomization +2 ng/ml). There is a 2:1 randomization between intervention and observation group. Patients with PSA progression in the observation group are offered a new diagnosis. This should preferably correspond to the initial diagnosis.

Therapy is performed for all patients in the intervention arm using high dose radiation therapy, either as conventional fractional irradiation with 2 Gy/fraction up to a total dose of 50 Gy or as hypofractional irradiation with a single dose of 10 Gy up to a total dose of 30 Gy.

The decision as to which regimen the patient is to be treated according to is made by the treating physician, taking into account in particular the location of the volume to be irradiated in relation to the organs at risk and any previous irradiation.

Being tested
local ablative radiotherapy
Keywords
Oligometastatic Disease, Prostate Cancer, Radiation therapy, Prostatic Cancer, Castration-Resistant
Medical subject headings
Prostatic Neoplasms, Castration-Resistant, Prostatic Neoplasms

What participants receive

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

  • local ablative radiotherapyRadiation

    Also called Photons

    Within the scope of the study, irradiation with two irradiation schemes is possible (the scheme applied is recorded in the CRF):

    • Scheme A 3*10 Gy (once a day, 2-3 days a week)
    • Scheme B 25*2 Gy (once a day, 5 days a week) The decision which irradiation scheme (3*10 Gy or 25*2 Gy) to use is made by the treating physician based on the anatomical position, the size of the metastases and the expected normal tissue load. Hypofractionated irradiation in three fractions is only possible if the limit values for the risk organs are adhered to. Radiotherapy should be performed with photons.
Study groups in NCT04141709
Study groupRoleWhat they receive
local ablative radiotherapyExperimentalThe therapy is performed for all patients in the intervention arm using high-dose radiation therapy, either as conventional fractional irradiation with 2 Gy/fraction up to a total dose of 50 Gy or as hypofractional irradiation with a single dose of 10 Gy up to a total dose of 30 Gy.
Receives: Radiation: local ablative radiotherapy
Observational groupNo interventionEffectiveness is measured as the rate in patients with PSA progression one year after randomization (defined as PSA nadir after randomization +2 ng/ml). There is a 2:1 randomization between intervention and observation group.

What is being measured

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

  1. Time to PSA progression

    Time to PSA progression (defined as PSA nadir after randomization +2ng/ml)

    Measured: 12 month after randomization

Secondary outcomes (6)

  1. Change of PSA doubling time

    PSA doubling time measured with the last three consecutive PSA values. Change of PSA doubling time compared to value before treatment

    Measured: 12 month after randomization

  2. Number of patients without detection of new lesions

    Number of patients without detection of new lesions at 12 months

    Measured: 12 month after randomization

  3. Toxicity (CTCAE 5.0)

    description of toxicity (CTCAE 5.0) ant 3 and 12 months.

    Measured: 3 and 12 month after therapy

  4. Number of patients who have PSA response

    Number of patients who have a PSA reduction of >50% at 12 months.

    Measured: 12 month after randomization

  5. Time to tumor-specific systemic therapy after intervention

    Time to tumor-specific systemic therapy after intervention (i.e. chemotherapy)

    Measured: 12 month after randomization

  6. Number of patients with a limited number of metastases at PSA progression

    Number of patients with a limited number of metastases at PSA progression, compared to patients with multiple metastases. (Arm B only)

    Measured: 12 month after randomization

Timeline

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

  1. First posted28 Oct 2019
  2. Study start1 Dec 2019
  3. Primary completion28 Apr 2027 (estimated)
  4. Study completion28 Apr 2027 (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
Randomised
Intervention model
Parallel groups
Model description
2:1 randomized allocation to intervention (local ablative radiotherapy) or standard of care
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04141709
Sponsor's protocol ID
STR - Oli-CR-P - 2018
Acronym
OLI-CR-P
Status last verified
Aug 2026
First submitted
24 Oct 2019
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Holscher T, Lohaus F, Koi L, Kotzerke J, Hoberuck S, Thomas C, Borkowetz A, Lock S, Krause M, Troost EGC. Ablative radiotherapy in castration-resistant prostate cancer. BJU Int. 2026 Jul 2. doi: 10.1111/bju.70368. Online ahead of print.

    PubMed 42389925

Questions about this trial

What is this clinical trial studying?

A study testing local ablative radiotherapy in people with Oligometastatic Disease and Prostatic Cancer, Castration-Resistant, run by Technische Universität Dresden at 4 sites in Germany.

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 10 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in 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?

This study is still under way. Results are not available in the source record yet.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to PSA progression (time frame: 12 month after randomization). 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 NCT04141709, 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 1 Sep 2026.

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