Fractionated stereotactic radiotherapy plus second-generation antiandrogen for oligometastatic patients with castration-resistant prostate cancer. Phase II Spanish study, prospective, multicenter. (OLIGORESIST)

Phase 1

Recruiting

• Conditions: Oligometastatic patients with castration-resistant prostate cancer; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-505024-62-01
• Lead Sponsor: Instituto de investigación en Oncología radioterápica FEOR (Fundación Española de Oncología RT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-05
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 51

Inclusion Criteria

Patients with histologically prostate adenocarcinoma, confirmed with a biopsy., Biochemistry progression confirmed according to Phoenix criteria, with testosterone in castration levels (testosterone <50 ng/ml or 1.7 nmol/L)., Radiological confirmation (with choline-PET/CT or 68Ga-PSMAPET/CT) of =5 node or bone metastasis, non-visceral, eligible to receive SBRT treatment (< 3 cm major diameter in bone metastases, < 5 cm in lymph node metastases)., Patients candidate to receive treatment with abiraterone or enzalutamide as per clinical routine, and treatment selection and prescription assigned by responsible physician before the inclusion in the study., Patients must provide written informed consent., Life expectancy > 3 months.

Exclusion Criteria

Patients with prostate carcinoma with histology other than adenocarcinoma., No previous biopsy., > 5 metastasis, Patients with visceral metastasis and or metastasis non elegible to receive SBRT., Patients with Testosterone above castration levels., Patients with prior treatment with docetaxel as first-line CRPC treatment (previous docetaxel treatment is permitted when administered as hormone-sensitive metastatic prostate cancer treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the PRFS measured from the time of initiation of secondgeneration antiandrogen to the time of radiological progression by choline PET/CT or 68Ga-PSMA PET/CT, in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.;Secondary Objective: Overall survival (time from initiation of second-generation antiandrogen to exitus) in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT., Quality of life of these patients using the European Organization for Research and Treatment of Cancer (EORTC) quality of life scale, EORTC QLQ-C30, validated for oncology patients., Acute and chronic toxicity according to the Common Terminology Criteria for Adverse Events (CTCAEv5.0) scale.;Primary end point(s): Radiological progression by choline PET/CT or 68Ga-PSMA PET/CT, in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Overall survival (time from initiation of second-generation antiandrogen to exitus) in patients with mCRPC treated with the combination of second-generation antiandrogen plus SBRT.;Secondary end point(s):Quality of life of these patients using the European Organization for Research and Treatment of Cancer (EORTC) quality QLQ-C30, validated for oncology patients. of life scale, EORTC .;Secondary end point(s):Acute and chronic toxicity according to the Common Terminology Criteria for Adverse Events (CTCAEv5.0) scale.