Stereotactic body radiotherapy for hormone-sensitive prostate cancer with few metastases
Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer
This study is testing whether a special type of targeted radiation therapy combined with standard treatment can help men with hormone-sensitive prostate cancer that has spread to a few places live longer and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Umeå University Academic / other |
| Locations | 7 sites (Lund, Lund and 6 other locations) |
| Trial ID | NCT04983095 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of metastasis-directed stereotactic body radiotherapy (MD-SBRT) combined with standard treatment for patients with hormone-sensitive prostate cancer that has spread to a limited number of sites. Participants will be randomly assigned to receive either MD-SBRT along with standard androgen deprivation therapy or standard treatment alone. The study aims to assess failure-free survival as the primary endpoint, while also examining secondary outcomes such as overall survival and treatment-related toxicity. Patients will be monitored for a minimum of five years to gather comprehensive data on treatment effects and safety.
Who should consider this trial
Good fit: Ideal candidates include men with hormone-sensitive prostate cancer and 1-3 metastases detected by PSMA-PET/CT.
Not a fit: Patients with castration-resistant prostate cancer or those who have received prior treatments affecting PSA levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and quality of life for patients with oligometastatic hormone-sensitive prostate cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed prostate cancer (ICD-O-3 C61) 2. WHO/ECOG performance status 0-1 3. 1-3 skeletal or extra pelvic lymph node metastases detected by PSMA-PET/CT in de novo prostate cancer or PSA-relapse after definitive RT or prostatectomy 4. Willing and able to provide informed consent- Exclusion Criteria: 1. Castration resistant prostate cancer (progression with castrate levels of testosterone) 2. Any treatment known to affect PSA (including ADT) for prostate cancer within 6 months (exception: ADT started due to oligometastatic disease within 2 weeks of study entry) 3. Patient eligible for other treatment (e.g., early docetaxel) than standard treatment described in the protocol as judged by treating physician 4. Life expectancy \<3 years by any reason, including concomitant or previous malignancies 5. Previous radiotherapy or surgery that may interfere with the planned treatment (including intra-prostatic recurrence if previous RT to the prostate) 6. \> 3 PSMA-PET/CT positive target lesions (excluding the prostate and regional lymph node metastasis in de novo patients or prostate bed and or regional lymph node metastasis in recurrent patients) 7. PSMA-PET verified metastases other than skeletal or lymph nodes 8. Metastases in base of scull and/or calotte 9. Any target lesions not treatable with image guided RT (IGRT) due to overlap with previous RT fields or exceeded dose constraint to OAR(s) as specified in study protocol
Where this trial is running
Lund, Lund and 6 other locations
- Region Skåne — Lund, Lund, Sweden (Recruiting)
- Capio St Göran Hospital — Stockholm, Region Stockholm, Sweden (Recruiting)
- Södersjukhuset — Stockholm, Region Stockholm, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Stockholm County, Sweden (Recruiting)
- Umeå University hospital — Umeå, Umea, Sweden (Recruiting)
- Ryhovs county hospital — Jönköping, Sweden (Recruiting)
- Region Örebro Län — Örebro, Örebro County, Sweden (Recruiting)
Study contacts
- Principal investigator: Karin Söderkvist — Region Västerbotten, Umeå University
- Study coordinator: Karin Söderkvist, MD,PhD
- Email: karin.soderkvist@umu.se
- Phone: +46 90 7853222
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.