Department of Radiation Oncology

Clinical Research Genitourinary Cancers

Strategic Direction and Overarching Themes for the Service

Clinical and translational research in the genitourinary service in the department of Radiation Oncology at the University of Pennsylvania focuses on:

  • The use of proton therapy in a number of disease sites, including prostate cancer, seminoma, and bladder cancer, assessing feasibility and treatment outcomes
  • Exploring the use of a circulating tumor cell assay in bladder cancer.
  • The impact of yoga on quality of life in prostate cancer patients receiving high-dose radiotherapy.

Description of Programs and Protocols within the Service

Title: A Phase II Trial of Proton Radiation Therapy Using Standard Fractionation for Low and Low-Intermediate Risk Adenocarcinoma of the Prostate

Principal Investigator: Neha Vapiwala, M.D.
Coordinator: Susan Mazzoni, MPH
Office: (215) 300-1153
UPCC#: 08809

This is a prospective study of patients undergoing standard fractionation (44 treatments) proton radiation for prostate cancer. The aims of this study are to assess acute and late toxicities due to radiation therapy, to determine freedom from failure, determine overall survival, and evaluation of the quality of life of subjects. Patients are eligible if they have histologically confirmed disease with clinical stages T1a to T2c N0M0, Gleason score 2-7, PSA <20ng/ml, and ECOG status 0-1. Subjects complete quality of life measures and specific GU/GI measures at baseline (before radiation treatment begins) and at each post-treatment follow-up visit.

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Title: A Phase II Trial of Proton Radiation Therapy or Intensity-Modulated Radiation Therapy Using Mild Hypofractionation for Low and Intermediate Risk Adenocarcinoma of the Prostate

Principal Investigator: Neha Vapiwala, M.D.
Coordinator: Susan Mazzoni, MPH
Office: (215) 300-1153
UPCC#: 18809

This is a prospective study of patients undergoing mild hypofractionation fractionation (28 treatments) proton radiation or IMRT for prostate cancer. This study seeks to assess acute and late toxicities due to radiation therapy, determine freedom from failure, determine overall survival, and evaluation of the quality of life of subjects. Patients are eligible if they have: histologically confirmed disease with clinical stages T1a to T2b N0M0, Gleason score 2-7, PSA <20ng/ml, and ECOG status 0-1. Subjects complete quality of life measures and specific GU/GI measures at baseline (before radiation treatment begins) and at each post-treatment follow-up visit.

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Title: PARTIQoL: Prostate Advanced Radiation Technologies Investigating Quality of Life, A Phase III Randomized Clinical Trial of Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer

Principal Investigator: Justin Bekelman, M.D.
Coordinator: Allison Schnader
Office: (215) 662-6418
UPCC#: 13812

This is a phase III multi-center randomized study that seeks to compare 2 types of standard of care therapies (IMRT and Proton) used for the treatment of men diagnosed with low or intermediate risk prostate cancer. This study is investigating whether men being treated for prostate cancer have the same amount of side effects, good and/or bad from either IMRT or proton therapy. Patients on study will be randomized to either IMRT or Proton therapy. To be eligible for the study, there are a number of eligibility requirements that the patient’s physician will review to see if a patient is eligible to enroll. The most noted eligibility requirements are a diagnosis of prostate cancer that is either low or intermediate risk, and the patient must be at least 18 years of age.

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Title: Yoga for Radiation Side Effects in Prostate Cancer

Principal Investigator: Neha Vapiwala, M.D.
Coordinator: Jerry Chen
Office: (215) 662-7449
UPCC#: 05813

This study seeks to determine the feasibility of implementing yoga interventions in men with prostate cancer and the effects of yoga on the fatigue, sexual dysfunction and urinary dysfunction related to radiation treatment. This study enrolls English speaking men who are 18 and older undergoing radiation therapy for a confirmed diagnosis of prostate cancer. Patients enrolled on this study attend twice weekly yoga sessions throughout the duration of their radiation treatment and complete study Quality of Life questionnaires once prior to beginning radiation, every two weeks while receiving radiation treatment, and a final time after attending their final yoga class.

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Title: Randomized Phase II Trial of Postoperative Adjuvant IMRT Following Cystectomy for pT3/pT4 Urothelial Bladder Cancer

Principal Investigator: John Christodouleas, M.D., MPH 
Coordinator: Susan Prendergast, RN, CCRP
Office: (215) 662-4267
UPCC#: NRG-GU001

The purpose of this interventional trial is to compare any good and bad effects of the following two treatment approaches: 1.) the standard approach which is surgery with or without chemotherapy or  2.) adding radiation therapy after the standard approach (surgery with or without chemotherapy). This study seeks to determine whether this different approach is better, the same, or worse than the usual approach. To be eligible for this trial, patient’s must be at least 18 years of age or older, have a diagnosis of muscle invasive urothelial carcinoma and have undergone a radical cystectomy with ileal conduit.

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Title: A Pilot Feasibility Study of Definitive Concurrent Chemoradiation with Pencil Beam Scanning Proton Beam in Combination with 5-Fluorouracil and Mitomycin-C for Carcinoma of the Anal Canal

Principal Investigator: Edgar Ben-Josef, M.D.
Coordinator: Dana Patsch
Office: (215) 615-5645
UPCC#: 23214

This is a pilot study evaluating the feasibility of definitive concurrent chemoradiation with pencil beam scanning proton beam in combination with 5-fluorouracil (5-FU) and mitomycin-C (MMC) for carcinoma of the anal canal. Anal cancer is highly curable with a combination of chemotherapy and radiation. However, the toxicity of this treatment is high. Proton therapy allows us to deliver similar doses to the pelvic targets but with less dose to normal organs uninvolved by the cancer. We anticipate that this reduction in radiation dose to normal tissue will increase treatment compliance, reduce interruptions (which are potentially detrimental to cancer control) and reduce side effects significantly.

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Title: Phase I/II Trial of Pre-Operative Image Guided Intensity Modulated Proton Radiation Therapy (IMPT) or Photon (IMRT) with Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas

Principal Investigator: William Levin, M.D.
Coordinator: Dana Patsch
Office: (215) 615-5645
UPCC#: 4214

This is a Phase I/II study of pre-operative image guided IMPT (IG-IMPT) or IMRT with simultaneously integrated boost (SIB) to the high risk margin of retroperitoneal sarcoma. The phase I portion of this study will evaluate up to four dose levels of IGIMPT or IMRT with simultaneously integrated boost (SIB) to the high risk margin of retroperitoneal sarcoma. Once the maximum tolerated dose (MTD) is determined (Phase I), participants will be accrued to the Phase II treatment using the combination of IG-IMPT or IMRT with SIB to determine if there is a sufficient signal, with respect to local recurrence, to warrant pursuing a large phase IIR or phase III trial. 

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Title: Retreatment of Recurrent Tumors Using Proton Radiotherapy

Principal Investigator: John P. Plastaras, M.D., Ph.D.
Coordinator: Kristi Lelionis, MS, CCRP
Office: (215) 615-3273
UPCC#: 23309

The purpose of this study is to determine the feasibility of using proton radiotherapy for reirradiation of recurrent malignancies. The primary outcomes are feasibility and acute toxicity. The study is infeasible if patient cannot be given treatment. Patient is unable to tolerate 15% treatment. patient is unable to complete all of his/her treatments within 10 days of estimated date of treatment completion. Acuite Toxicity is defined as any grade 4 toxicity observed within 90 days from the initiation of radiotherapy that is felt to be directly related to their proton treatment. Toxicities will be graded by NCI CTC Version 4.0. Patients will be stratified by treatment site (Head and Neck, Thorax, Abdomen, Pelvis, Extremities) and by treatment volume (low volume, high volume) for a total of 10 strata. This study will be done in two phases. In the first phase, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 90 days after the last patient in the initial phase has completed treatment in each strata and once feasibility has been verified. 

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Title: Prospective Follow-Up of Outcomes in Patients Receiving Photodynamic Therapy for Neoplastic Diseases

Principal Investigator: Charles Simone, M.D.
Coordinator: Ashley Feriozzi
Office: (215) 615-3272
UPCC#: 06911

This is an observational study for subjects who are age 18 or older and will undergo Photodynamic Therapy (PDT) for a diagnosis of neoplastic disease under the direction of a Penn physician. The purpose of this study is to learn and understand more about how PDT works. To do this we need to study the experiences of patients who undergo PDT and examine things like tumor type, other medical conditions, other therapies and treatment results.There are no interventions being performed and only medical record data will be collected. We will collect your name, medical record number, date of birth, date of initiation of specific therapies such as surgery, radiation or PDT. This information will not be disclosed to others outside of the study team. The entire study is anticipated to take 10 years. Asubject will be in the study until they inform us that they no longer wish to participate.

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Title: RADVAX: A Stratified Phase I Trial of Pembrolizumab with Hypofractionated Radiotherapy in Patients with Advanced and Metastatic Cancers

Principal Investigator: Amit Maity, M.D. Ph.D.
Coordinator: Dana Patsch
Office: (215) 615-5645
UPCC#: 40914

Phase I clinical trial of hypofractionated radiotherapy to an isolated index lesion in combination with the PD-1 inhibitor, Pembrolizumab in patients with metastatic cancers who have failed anti-PD-1 therapy (melanoma and NSCLC) and patients with metastatic cancers who have have progressed after at least one regimen of systemic therapy (breast, pancreas, and other).

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