What is this study testing for men with oligometastatic castration-resistant prostate cancer?

This study is evaluating the combination of fractionated stereotactic radiotherapy (SBRT) with second-generation antiandrogen drugs to understand their effects on survival, safety, and quality of life. The research focuses on men with limited metastatic prostate cancer resistant to hormone therapy. The study is led by the Instituto de Investigación en Oncología Radioterápica.

Who may be eligible for this prostate cancer clinical trial?

Men diagnosed with prostate adenocarcinoma confirmed by biopsy, with testosterone levels in castration range, and up to 5 non-visceral metastases eligible for SBRT may qualify. Candidates should be starting or have started second-generation antiandrogen therapy recently and have a life expectancy greater than 3 months. Please review eligibility criteria for more details.

Is there any cost to participate in this prostate cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should consider these factors when planning their involvement.

Actively Recruiting

Phase 2

MALE

ID07717268

Phase II Trial of Fractionated Stereotactic Radiotherapy Combined with Second-Generation Antiandrogens for Men with Limited Metastatic Castration-Resistant Prostate Cancer

Led by Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic · Updated on 2026-07-21

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the outcomes of combining fractionated stereotactic body radiotherapy SBRT with second-generation antiandrogens in men diagnosed with oligometastatic castration-resistant prostate cancer mCRPC with up to five metastases. This phase II, multicenter, prospective study aims to assess survival, safety, and quality of life in patients receiving this combination treatment. The focus is on prostate cancer patients who have progressed despite hormone therapy but have limited metastatic disease eligible for SBRT. Participants will start second-generation antiandrogen therapy, such as abiraterone or enzalutamide, prescribed by their physician according to clinical practice. SBRT will be administered between two and eight weeks after starting the antiandrogen treatment. The antiandrogen therapy will continue until radiological disease progression, intolerable side effects, or death. Follow-up will continue for up to 36 months after completing SBRT or until the participants death. During the study, participants will undergo imaging with choline PETCT or 68Ga-PSMA PETCT before inclusion, clinical and functional assessments, blood tests, and quality of life questionnaires. Researchers will measure progression-free survival based on radiological evaluation, overall survival, quality of life using the EORTC QLQ-C30 scale, and acute and chronic toxicities using standard criteria. The total duration of participation may last up to six years, including recruitment and follow-up periods.

CONDITIONS

Brief Title

Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients.

Who Can Participate

MALE

Eligibility Criteria

You may qualify if you...

Male patients with biopsy-confirmed prostate adenocarcinoma
Testosterone levels in biochemical castration range (below 50 ng/ml or 1.7 nmol/L) with documented progression
Radiological confirmation of up to 5 non-visceral metastases eligible for SBRT
Candidates for treatment with abiraterone or enzalutamide, started treatment no more than 14 days before signing consent
Ability to provide written informed consent
Life expectancy greater than 3 months

You will not qualify if you...

Prostate carcinoma with histology other than adenocarcinoma
No previous biopsy confirming prostate cancer
More than 5 metastases or metastases not treatable in 5 SBRT fields
Presence of visceral metastasis or metastases not eligible for SBRT
Testosterone levels above castration range
Prior docetaxel treatment as first-line for castration-resistant prostate cancer

Your Study Journey

Screening

Duration - Up to 8 weeks before treatment start

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Until radiological progression or intolerance

Participants start second-generation antiandrogen therapy and receive SBRT between 2 and 8 weeks after starting the drug. Antiandrogen therapy continues until disease progression, poor tolerance, or death.

Follow-up

Duration - Up to 36 months

Participants are monitored for up to 36 months after completing SBRT or until death. Assessments include imaging, blood tests, quality of life questionnaires, and toxicity evaluations.