Clinical trial for Prostate Cancer
Official title Hypofractionated WPPT With HDR Boost
ClinicalTrials.gov ID: NCT06591819
What this study is testing
- What it's testing
- This study aims to see if a specific type of radiation therapy is safe and effective for treating prostate cancer that has a higher risk of spreading to nearby lymph nodes.
- Who it's for
- The study is looking for men with high-risk or unfavorable intermediate-risk prostate cancer who have an elevated risk of lymph node involvement.
- What's involved
- Participants will receive ultrahypofractionated whole pelvis proton therapy, which is a form of radiation, along with a brachytherapy boost, which involves placing a small radiation source inside the body.
- Time commitment
- The source text does not specify the total duration of the study or the number of visits required.
- Phase 2: a mid-size study of how well it works
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
You may be able to join if
- Pathologic evidence of prostate cancer
- Risk group: high or intermediate risk as defined below
- High risk: T3a or Gleason Grade Group 4/5 or PSA \>20
- Unfavorable intermediate risk disease: at least one or more of the following: T2b-T2c, Gleason Grade Group 2/3, PSA 10-20, \>50% of cores positive
- Must be appropriate for whole pelvis per the treating oncologist or based on lymph node predicting nomogram
You likely can't join if
- Evidence of distant metastatic disease
- History of inflammatory bowel or active collagen/vascular/connective tissue disorders
- Prior radiation to the pelvis
- Prior or concurrent second invasive malignancy other than non-melanoma skin cancers, unless disease free for minimum of five years
- Known severe, active co-morbidity, defined as follows: o Any clinically significant unrelated systemic illness, medical condition, or other factor...
- Patients should not have a prior history of TURP
See the full eligibility criteria
- Pathologic evidence of prostate cancer
- Risk group: high or intermediate risk as defined below
- High risk: T3a or Gleason Grade Group 4/5 or PSA \>20
- Unfavorable intermediate risk disease: at least one or more of the following: T2b-T2c, Gleason Grade Group 2/3, PSA 10-20, \>50% of cores positive
- Must be appropriate for whole pelvis per the treating oncologist or based on lymph node predicting nomogram
- No prior radiotherapy in the region of study
- No inflammatory bowel disease, active collagen/vascular/connective tissue disorders
- Age ³18 years
- ECOG performance status: 0-2
- Patients may initiate androgen deprivation therapy up to 3 months prior to radiation start, concurrently, or up to 3 months after completion of radiation therapy start.
- Pretreatment evaluation
- History \& Physical by a radiation oncologist within 6 weeks of enrollment
- MRI prostate
- PSMA PET
- PSA level
- Eligible for rectal spacer procedure as determined by treating physician
- Informed consent: Patients must have the ability to understand and be willing to sign the study-specific informed consent indicating their understanding of the investigational nature and the risks of this study before...
- Evidence of distant metastatic disease
- History of inflammatory bowel or active collagen/vascular/connective tissue disorders
- Prior radiation to the pelvis
- Prior or concurrent second invasive malignancy other than non-melanoma skin cancers, unless disease free for minimum of five years
- Known severe, active co-morbidity, defined as follows: o Any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the Principal Investigators, would interfere...
- Patients should not have a prior history of TURP
- Patients should not have pre-treatment IPSS \>20 or on maximum alpha-blocker medications at baseline
- Patients should not be on therapeutic anticoagulation
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, United States
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, but 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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.