New treatment for high-risk prostate cancer using carbon ions and photon radiotherapy
Carbon Ions Boost Followed by Pelvic Photon Radiotherapy for High Risk Prostate Cancer
This study is testing a new treatment for high-risk prostate cancer that combines carbon ion therapy with traditional radiation to see if it can better target tumors while protecting healthy tissue.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Milan) |
| Trial ID | NCT02672449 on ClinicalTrials.gov |
What this trial studies
This research project aims to evaluate the safety and feasibility of a novel treatment schedule for high-risk prostate cancer. The approach involves administering a high-dose carbon ions boost to the prostate tumor, followed by pelvic intensity-modulated radiation therapy (IMRT) using photons. A total of 65 patients will be enrolled in this prospective phase II trial across three institutions in Italy. The treatment aims to optimize tumor targeting while minimizing damage to surrounding healthy tissues.
Who should consider this trial
Good fit: Ideal candidates for this study are men with histologically confirmed high-risk adenocarcinoma of the prostate who meet specific eligibility criteria.
Not a fit: Patients with pelvic lymph node or distant metastasis, severe urinary obstructive symptoms, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with high-risk prostate cancer, potentially improving their outcomes.
How similar studies have performed: While the use of carbon ions in radiotherapy is established, this specific combination approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate, high-risk category according to NCCN version 2013 (T3a and/or PSA \> 20 ng/ml and/or Gleason score of 8-10) * cN0 and cM0 * Good performance status (ECOG\<2) * No previous pelvic RT * No previous prostatectomy * No concomitant bowel inflammatory disease or other serious comorbidities * Good urinary flow (peak flow \> 10 ml/s) * No previous invasive cancer (within 5 years before the PCa diagnosis) apart from non-melanoma skin malignancies. Exclusion criteria * Pelvic lymph node metastasis (N1) * Distant metastasis (M1) * Urinary obstructive symptoms (IPSS \> 20) * Previous pelvic radiotherapy * Severe systemic disorders * Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin) * Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer * Non conformity of the radiotherapy dose distribution when compared to the dose constraints * Psychiatric disorders or any other condition that can can make unreliable the informed consent
Where this trial is running
Milan
- European Institute of oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Roberto Orecchia, MD — European Institute of Oncology
- Study coordinator: Roberto Orecchia, MD
- Email: roberto.orecchia@ieo.it
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.