RECRUITING

Hypofractionated WPPT With HDR Boost

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety of Hypofractionated Whole-Pelvis Proton Therapy With HDR Boost

Quick Facts

Study Start:2024-10-28

Study Completion:2031-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06591819

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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);	* 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: * 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

Inclusion Criteria

Exclusion 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);

* 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:
* 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

Contacts and Locations

Study Contact

Project Manager

CONTACT

215-662-3790

RadOncCRU@PennMedicine.upenn.edu

Principal Investigator

Arun Goel, MD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

Arun Goel, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-28

Study Completion Date2031-10

Study Record Updates

Study Start Date2024-10-28

Study Completion Date2031-10

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer