Investigating Elective Para-Aortic Radiotherapy for Prostate Cancer
Phase II Trial to Investigate the Benefit of Elective Para-Aortic Radiotherapy (PART) for pN1 Prostate Cancer Using Arc Therapy (IMAT/VMAT)
This study is testing whether adding targeted radiotherapy to the treatment of men with prostate cancer that has spread to nearby lymph nodes can help them live longer without the cancer coming back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 137 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Leuven) |
| Trial ID | NCT03079323 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial aims to evaluate the effectiveness of elective para-aortic radiotherapy (PART) in men with prostate cancer who have histologically confirmed pelvic lymph node metastasis (pN1) after extended pelvic lymph node dissection. The study compares outcomes of patients receiving PART to those historically treated with whole pelvic radiotherapy alone. The primary goal is to determine if PART improves clinical relapse-free survival over five years, while secondary objectives include assessing toxicity, quality of life, and time to disease progression. This non-randomized trial will provide insights into the potential benefits of adding PART to standard treatment.
Who should consider this trial
Good fit: Ideal candidates are men over 18 with histologically confirmed prostate cancer and pN1 disease after extended pelvic lymph node dissection.
Not a fit: Patients with recurrent disease or those with advanced metastatic disease (cM1a, cM1b, or cM1c) will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve disease control and survival rates for patients with pN1 prostate cancer.
How similar studies have performed: While the approach of elective para-aortic radiotherapy is being explored, this specific trial is novel and aims to provide new insights into its efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent and willingness to comply with the treatment and follow-up * Diagnosis of histopathologically confirmed prostate cancer * No former treatment for prostate cancer * Presence of pN1 disease after ePLND (criteria defined in the protocol) * Age \> 18 * Karnofsky Performance score \> 70 * Ability to understand the informed consent (Helsinki Declaration) Exclusion Criteria: * Recurrent disease status * Presence of cM1a, cM1b or cM1c disease * Former radiotherapy making WPRT and/or PART impossible * Prior malignancy, not disease-free \> 5 years, except basocellular skin epithelioma * Severe or active comorbidity likely to impact on the feasibility of WPRT and/or PART * Disorder precluding understanding of trial information
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Gert De Meerleer, Prof. Dr. — UZ Leuven
- Study coordinator: Gert De Meerleer, Prof. Dr.
- Email: gert.demeerleer@uzleuven.be
- Phone: 00 32 16 34 76 00
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.