Phase II trial testing Ablative radiotherapy in metastatic prostate cancer, resistant to hormonal therapy and with number of metastatic lesions lower or equal to three.

A 2 arm, phase II controlled randomized trial comparing efficacy and safety of abiraterone and abiraterone associated with Ablative Radiation Therapy in patients with Oligometastatic castration resistant prostate cancer (ARTO trial) - ARTO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005284-13-IT

Enrollment

174

Registered

2021-02-09

Start date

2018-10-09

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oligometastatic prostate cancer, castration resistant MedDRA version: 21.1 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: ZYTIGA - 250 MG - COMPRESSA - USO ORALE - FLACONE 120 COMPRESSE Product Name: Zytiga Product Code: [41427016] Pharmaceutical Form: Tablet INN or Proposed INN: abiraterone acetato CAS Numbe

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Metastatic disease and only minor or equal at 3 metastatic sites recorded (irrespective if nodal or bone). 2. Patients should have received abiraterone acetate for 30 days before start of radiotherapy (+ or – 3 days) 3. Asymptomatic or mildly symptomatic pa-tients according to clinical judgement. 4. Age more and equal 18 years. 5. Subject must have signed an informed consent document indicating that they understand the purpose of procedures required for the study and are willing to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 114

Exclusion criteria

Exclusion criteria: 1. More than 3 metastatic lesions. 2. Visceral envolvement. 3. Known or suspected contraindications or hypersensitivity to Abiraterone, GnRH agonist/antagonist or Radiotherapy. 4. Comorbidities that contraindicate Abiraterone, GnRH agonist/antagonist or Radiotherapy. 5. Any condition for which, in the option of the investigator, participation would not be in the best interest of subject. 6. Patients who received previous therapies for mCRPC (excluded ormonal therapy)

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective of the study will be PSA response >50% measured within 6 months.in nodal and/or bone oligometastatic (¿ 3 lesions), castration resistant prostate cancer patients undergoing SBRT in combination with AA (experimental arm), respect to patients treated with AA (control arm).;Secondary Objective: -To assess, during the observation period, the radiographic progression free survival (rPFS) and/or biochemical PFS in nodal and/or bone oligometastatic (¿ 3 lesions) castration resistant prostate cancer patients undergoing SBRT in combination with AA (experimental arm), respect to patients treated with AA (control arm). -To describe SBRT+AA safety. -To compare PSA trend in the two treatment arms during the observation period. -To compare the overall survival (OS) in the two treatment arms. - To describe quality of life (QoL) data, as measured by EORTC QLQ-C30 during the observation period. -To describe the use of analgesic drugs and pain experience by means presence/absence of symptoms assessed by the Brief Pain Inventory Short Form (BPISF) ;Primary end point(s): Primary objective of the study will be PSA response >50% measured within 6 months.in nodal and/or bone oligometastatic (¿ 3 lesions), castration resistant prostate cancer patients undergoing SBRT in combination with AA (experimental arm), respect to patients treated with AA (control arm).;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: Primary objective of the study will be PSA response >50% measured within 6 months.in nodal and/or bone oligometastatic (¿ 3 lesions), castration resistant prostate cancer patients undergoing SBRT in combination with AA (experimental arm), respect to patients treated with AA (control arm).;Secondary Objective: -To assess, during the observation period, the radiographic progression free survival (rPFS) and/or biochemical PFS in nodal and/or bone oligometastatic (¿ 3 lesions) castration resistant prostate cancer patients undergoing SBRT in combination with AA (experimental arm), respect to patients treated with AA (control arm). -To describe SBRT+AA safety. -To compare PSA trend in the two treatment arms during the observation period. -To compare the overall survival (OS) in the two treatment arms. - To describe quality of life (QoL) data, as measured by EORTC QLQ-C30 during the observation period. -To describe the use of analgesic drugs and pain experience by means presence/absence of symptoms assessed by the Brief Pain Inventory Short Form (BPISF) ;Primary end point(s): Primary objective of the study will be PSA response >50% measured within 6 months.in nodal and/or bone oligometastatic (¿ 3 lesions), castration resistant prostate cancer patients undergoing SBRT in combination with AA (experimental arm), respect to patients treated with AA (control arm).;Timepoint(s) of evaluation of this end point: 6 months

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Secondary

Measure	Time frame
Secondary end point(s): castration resistant prostate cancer patients undergoing SBRT in combination with AA; To compare PSA trend in the two treatment arms during the observation period.; To compare the overall survival (OS) in the two treatment arms.; To describe quality of life (QoL) data, as measured by EORTC QLQ-C30 during the observation period; To describe the use of analgesic drugs and pain experience by means pres-ence/absence of symptoms assessed by the Brief Pain Inventory Short Form (BPISF);Timepoint(s) of evaluation of this end point: 40 months; 40 months; 40 months; 40 months; 40 months	—

Measure

Time frame

Secondary end point(s): castration resistant prostate cancer patients undergoing SBRT in combination with AA; To compare PSA trend in the two treatment arms during the observation period.; To compare the overall survival (OS) in the two treatment arms.; To describe quality of life (QoL) data, as measured by EORTC QLQ-C30 during the observation period; To describe the use of analgesic drugs and pain experience by means pres-ence/absence of symptoms assessed by the Brief Pain Inventory Short Form (BPISF);Timepoint(s) of evaluation of this end point: 40 months; 40 months; 40 months; 40 months; 40 months

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Countries

Italy

Contacts

Public ContactData Manager

Dipartimento "Mario Serio" Univ. studi Firenze

datamanager.ng.rt@sbsc.unifi.it+390557947192

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026