Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT04983095
Eligibility 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04983095
Study Brief:
Protocol Section:
NCT04983095