RecruitingPhase 2

Hypofractionated WPPT With HDR Boost

Safety of Hypofractionated Whole-Pelvis Proton Therapy With HDR Boost

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase 2 study tests proton radiation to the whole pelvis in fewer treatment sessions, plus extra radiation placed inside the body near the prostate. It is for people with high-risk or unfavorable intermediate-risk prostate cancer and a higher risk of spread to nearby lymph nodes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and have prostate cancer confirmed by a tissue test.
  • Have high-risk cancer: stage T3a, Gleason Grade Group 4 or 5, or PSA above 20. Stage shows cancer spread, Grade Group shows how abnormal the cells look, and PSA is a blood test.
  • Or have unfavorable intermediate-risk cancer with at least one of these: stage T2b–T2c, Grade Group 2 or 3, PSA 10–20, or cancer in more than half of biopsy samples.
  • Be suitable for radiation to the whole pelvis, based on your cancer doctor's judgment or a tool that estimates lymph node risk.
  • Be able to receive radiation aimed at treating the cancer and be well enough to care for yourself and stay out of bed or a chair for at least half the day.
  • Have an exam by a radiation cancer doctor within 6 weeks before joining, a prostate MRI, a PSMA PET scan to look for cancer, and a PSA blood test.
  • Be able to have a rectal spacer procedure, which places space between the prostate and rectum, as judged by your doctor.
  • Be able to understand the study and sign a consent form before study-specific tests or procedures.

Who can't join

  • Cancer has spread to distant parts of the body.
  • Have a history of inflammatory bowel disease, or an active disorder affecting collagen, blood vessels, or connective tissue.
  • Have had radiation to the pelvis before.
  • Have another invasive cancer now or in the past, unless cancer-free for at least 5 years. Non-melanoma skin cancers are allowed.
  • Have a serious active illness or another condition that could make treatment unsafe or interfere with the study.
  • Have had TURP, a surgery that removes prostate tissue through the tube that carries urine.
  • Have a urine symptom score (IPSS) above 20 before treatment, or already take the highest dose of alpha-blocker medicine for urine symptoms.
  • Take blood-thinning medicine at a dose used to treat blood clots.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 therapy for the following months: unfavorable intermediate risk patients for 6 months; high-risk patients for 24 months. Patients will be allowed to discontinue ADT at physician and patient discretion. * 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 any of the protocol related studies are performed (this does not include routine laboratory testing or imaging studies required to establish study eligibility); Exclusion Criteria: * 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 in the safe and timely completion of study procedures, compromise the patient's ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or results. * 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

Study sites (1)

PA