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New treatment option for Prostate Cancer
Official title Hypofractionated WPPT With HDR Boost
ClinicalTrials.gov ID: NCT06591819
What this study is testing
- What it's testing
- This is a phase II study of ultrahypofractionated whole pelvis proton therapy with brachytherapy boost for patients with high risk or unfavorable intermediate risk prostate with elevated risk of lymph node involvement.
- 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
- Patient is a candidate for definitive external beam radiotherapy:
- 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. Patients may have received androgen deprivation...
- 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's taking place
- 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 - 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?
Study sites include Philadelphia, Pennsylvania, United States. 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.