Stereotactic body radiotherapy for hormone-sensitive prostate cancer with few metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.