Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer

Oligometastatic Disease Clinical Trial

— OLI-CR-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04141709
• Other study ID #: STR - Oli-CR-P - 2018
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2023
• Source: Technische Universität Dresden
• Contact: Tobias Hölscher, Dr.
• Phone: +493514582238
• Email: str.studien[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Treatment can be stereotactically hypofractionated or conventionally fractionated.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oligometastatic Disease
• Prostatic Cancer, Castration-Resistant
• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Intervention

Radiation:
• local ablative radiotherapy
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.

Locations

Country	Name	City	State
Germany	Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden	Dresden	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to PSA progression	Time to PSA progression (defined as PSA nadir after randomization +2ng/ml)	12 month after randomization
Secondary	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	12 month after randomization
Secondary	Number of patients without detection of new lesions	Number of patients without detection of new lesions at 12 months	12 month after randomization
Secondary	Toxicity (CTCAE 5.0)	description of toxicity (CTCAE 5.0) ant 3 and 12 months.	3 and 12 month after therapy
Secondary	Number of patients who have PSA response	Number of patients who have a PSA reduction of >50% at 12 months.	12 month after randomization
Secondary	Time to tumor-specific systemic therapy after intervention	Time to tumor-specific systemic therapy after intervention (i.e. chemotherapy)	12 month after randomization
Secondary	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)	12 month after randomization