Hemiablative focal brachytherapy for localized prostate cancer
Focal Low Dose Rate ( LDR) Brachytherapy: Hemi-ablative Treatment With LDR for Patients With Low and Low-tier Intermediate Risk Prostate Cancer
This study is testing a new way to treat localized prostate cancer by delivering targeted radiation to only half of the prostate to see if it reduces side effects and improves quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 60 Years and up |
| Sex | Male |
| Sponsor | St George Hospital, Australia Academic / other |
| Locations | 1 site (Kogarah, Sydney, New South Wales) |
| Trial ID | NCT02643511 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility and effectiveness of hemiablative low-dose-rate (LDR) brachytherapy for treating localized prostate cancer. The approach focuses on delivering a precise dose to only half of the prostate, potentially reducing toxicity to surrounding organs. The study will assess acute and late side effects, including rectal, urinary, and sexual toxicity, while also measuring quality of life changes using validated questionnaires. Additionally, local tumor control will be evaluated through biopsy outcomes following the treatment.
Who should consider this trial
Good fit: Ideal candidates include men aged 65 and older with low or low-tier intermediate prostate cancer and unilateral disease.
Not a fit: Patients with high-risk prostate cancer or those who are not fit for general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less toxic alternative for patients with localized prostate cancer.
How similar studies have performed: Other studies have shown promise with focal brachytherapy approaches, but this specific method is still being evaluated for its feasibility.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 1. Patients must have histologically proven adenocarcinoma of the prostate.
2. Patients must have low or low-tier intermediate prostate cancer
* Low risk prostate cancer patients must have:
* Clinical stage ≤ T2a,
* Gleason score =6 and iPSA ≤ 10 ng/ml
* \< 25% cores positive, \< 50 % cancer in each core involved
* Low tier Intermediate risk patients may have:
* Clinical stageT2a
* Gleason score ≤ 3+4=7
* PSA ≤ 10 ng/ml
* \< 25% cores positive, \< 50 % cancer in each core
3. Patients must be fit for general anesthetic. 4. Patients must have unilateral disease on biopsy 5. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
6. Men ≥ 65 years of age with a life expectancy estimated to be \>10 years. 7. Patients must have no contraindications to interstitial prostate brachytherapy.
8. Patients on anticoagulant therapy must be able to stop therapy safely for at least 7 days.
9. Patients must not have any contraindications to MRI 10. IPSS \<=16
Exclusion Criteria:
1. Does not meet staging criteria for low risk or low tier intermediate risk prostate cancer
2. Bilateral prostatic disease
3. Prior hormonal therapy
4. Prior Transurethral resection or middle lobe resection
5. Recent IPSS\>
6. Unfit for general anesthetic
7. MRI contraindicated
8. Unable to cease anticoagulant therapy
9. Life expectancy \< 10 years
10. IPSS\>16
Where this trial is running
Kogarah, Sydney, New South Wales
- St George Hospital Cancer Care Centre — Kogarah, Sydney, New South Wales, Australia (Recruiting)
Study contacts
- Study coordinator: Ana Fernandez, MD
- Email: Ana.Fernandezots@SESIAHS.HEALTH.NSW.GOV.AU
- Phone: +61291131306
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.