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New treatment option for Prostate Cancer Patients Undergoing External Radiation and Seed...
Official title Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions
ClinicalTrials.gov ID: NCT07343349
What this study is testing
- What it's testing
- Every year, about 700 Danish men get radiotherapy for prostate cancer with a high-risk of later progression. The risk of relapse is about 40 % after 5 - 8 years, so we need better treatment for these patients in Denmark and globally.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Patients with biopsy verified PCa with no distant metastases with either
- Intermediate- or high-risk PCa, defined as at least one of the following risk criteria:
- Clinical stage cT2c-T3b (UICC TNM 8th edition)
- Imaging stage, T3a or T3b
- ≥ Gleason score 4+3, (ISUP Grade groups 3,4 or 5)
You likely can't join if
- WHO performance status ≥ 2
- If, for any patient related reason, an MRI cannot be performed
- International prostate symptom score (IPSS) ≧ 20
- If fiducial markers cannot be inserted
- TURP within 3 months from start of treatment
- Previous pelvic irradiation
See the full eligibility criteria
- Patients with biopsy verified PCa with no distant metastases with either
- Intermediate- or high-risk PCa, defined as at least one of the following risk criteria:
- Clinical stage cT2c-T3b (UICC TNM 8th edition)
- Imaging stage, T3a or T3b
- ≥ Gleason score 4+3, (ISUP Grade groups 3,4 or 5)
- Regional lymph node metastases N1
- Age \> 18
- WHO score 0-1
- Intraprostatic lesion visible on MRI
- Suitable for focal boost
- Ability to give written informed consent and willingness to return for follow-up
- WHO performance status ≥ 2
- If, for any patient related reason, an MRI cannot be performed
- International prostate symptom score (IPSS) ≧ 20
- If fiducial markers cannot be inserted
- TURP within 3 months from start of treatment
- Previous pelvic irradiation
- If the patient is judged by the physician to be unable to adhere to trial activities
- History of chronic inflammatory bowel disease (CIBD)
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Copenhagen, Denmark
- Vejle, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Copenhagen, Denmark; Vejle, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.