Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04141709

Studienbeginn:
Dezember 2019

Letztes Update:
08.02.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Technische Universität Dresden

Collaborator:
-

Studienleiter

Tobias Hölscher, Dr.
Principal Investigator
Radiation Oncology, Technische Universität Dresden

Kontakt

Tobias Hölscher, Dr.
Kontakt:
Phone: +493514582238
E-Mail: str.studien@uniklinikum-dresden.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Tobias Hölscher, Dr.
Phone: +493514582238
E-Mail: str.studien@uniklinikum-dresden.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

This is a monocentric, 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.

Ein-/Ausschlusskriterien

Indication:

Oligometastases (1-5) in castration-resistant prostate carcinoma

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Studien-Rationale

Primary outcome:

1. Time to PSA progression (Time Frame - 12 month after randomization):
Time to PSA progression (defined as PSA nadir after randomization +2ng/ml)

Secondary outcome:

1. Change of PSA doubling time (Time Frame - 12 month after randomization):
PSA doubling time measured with the last three consecutive PSA values. Change of PSA doubling time compared to value before treatment

2. Number of patients without detection of new lesions (Time Frame - 12 month after randomization):
Number of patients without detection of new lesions at 12 months

3. Toxicity (CTCAE 5.0) (Time Frame - 3 and 12 month after therapy):
description of toxicity (CTCAE 5.0) ant 3 and 12 months.

4. Number of patients who have PSA response (Time Frame - 12 month after randomization):
Number of patients who have a PSA reduction of >50% at 12 months.

5. Time to tumor-specific systemic therapy after intervention (Time Frame - 12 month after randomization):
Time to tumor-specific systemic therapy after intervention (i.e. chemotherapy)

6. Number of patients with a limited number of metastases at PSA progression (Time Frame - 12 month after randomization):
Number of patients with a limited number of metastases at PSA progression, compared to patients with multiple metastases. (Arm B only)

Studien-Arme

Experimental: local ablative radiotherapy
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.
No Intervention: Observational group
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.

Geprüfte Regime

local ablative radiotherapy (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.

Quelle: ClinicalTrials.gov

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