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.
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
- Conditions the study is for
- Oligometastatic Disease, Prostatic Cancer, Castration-Resistant
- 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
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
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 group | Role | What they receive |
|---|---|---|
| local ablative radiotherapy | Experimental | The 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 group | No intervention | Effectiveness 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.
Time to PSA progression
Time to PSA progression (defined as PSA nadir after randomization +2ng/ml)
Measured: 12 month after randomization
Secondary outcomes (6)
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
Number of patients without detection of new lesions
Number of patients without detection of new lesions at 12 months
Measured: 12 month after randomization
Toxicity (CTCAE 5.0)
description of toxicity (CTCAE 5.0) ant 3 and 12 months.
Measured: 3 and 12 month after therapy
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
Time to tumor-specific systemic therapy after intervention
Time to tumor-specific systemic therapy after intervention (i.e. chemotherapy)
Measured: 12 month after randomization
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.
- First posted28 Oct 2019
- Study start1 Dec 2019
- Primary completion28 Apr 2027 (estimated)
- Study completion28 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oligometastatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Hölscher, Technische Universität Dresden
- Investigators
- Tobias Hölscher, Dr., Principal investigator, Radiation Oncology, Technische Universität Dresden
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