Proton therapy for localized prostate cancer
A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With a Localized Prostate Adenocarcinoma
NA · National Cancer Center, Korea · NCT03285815
This study tests whether a shorter course of proton therapy can effectively treat localized prostate cancer while causing fewer side effects compared to a longer treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Sex | Male |
| Sponsor | National Cancer Center, Korea (other gov) |
| Locations | 1 site (Ilsan, Gyenggi-do) |
| Trial ID | NCT03285815 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of hypofractionated proton therapy in patients diagnosed with localized prostate adenocarcinoma. Participants are randomly assigned to receive either 60 CGE of proton therapy over 20 days or 47 CGE over 10 days. The study aims to determine the optimal treatment regimen for improving patient outcomes while minimizing side effects. It includes patients with biopsy-proven prostate adenocarcinoma at specific stages and performance status.
Who should consider this trial
Good fit: Ideal candidates are men with biopsy-proven localized prostate adenocarcinoma at stages T1-T2cN0M0 and an ECOG performance status of 0-1.
Not a fit: Patients with postoperative residual or recurrent tumors, evidence of distant metastasis, or those who have received prior irradiation in the same location may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and less harmful option for patients with localized prostate cancer.
How similar studies have performed: Other studies have shown promise with proton therapy for prostate cancer, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0 * ECOG performance status:0-1 * Signed study specific informed consent prior to study entry. Exclusion Criteria: * Postoperative residual or recurrent tumor * Evidence of distant metastasis previous irradiation for the tumor in the same location * Adjuvant anti-androgenic hormonal therapy High risk group (NCCN guide line)
Where this trial is running
Ilsan, Gyenggi-do
- Kwanho Cho — Ilsan, Gyenggi-do, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Kwanho Cho — National Cancer Center, Korea
- Study coordinator: Kwanho Cho
- Email: kwancho@ncc.re.kr
- Phone: 82-31-920-1720
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.
Conditions: Prostate Adenocarcinoma