Mild Hypofractionation With Proton Therapy or IMRT for Intermediate-Risk Prostate Cancer

NCT01352429 | Active Not Recruiting

• 1 other identifier: UPCC 18809
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 2

Brief Summary

This is a study to first establish feasibility of the study and then to register the treatment data of adult patients with a diagnosis of intermediate risk of prostate cancer presenting for definitive radiation treatment with either proton radiotherapy or Intensity Modulated Radiation Therapy (IMRT). The investigators propose to employ a hypofractionated strategy with our image guided treatment to further improve cancer control and decrease toxicity.

Conditions

Prostate Adenocarcinoma

Keywords

adult; histologically confirmed

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events

  Unable to tolerate 10% of treatments using proton radiotherapy. Unable to complete all treatments. Cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised.

  Within 10 days

• Acute Toxicity

  Any grade 2 or higher GI or GU toxicity, other than GI or GU toxicity or any grade 3 or higher toxicity, other than GI or GU. In the feasibility phase of this trial, the observation window for acute toxicty is extended to 60 days from completion of radiotherapy, as a feasibility precaution.

  Within 60 days of completion of radiotherapy

Secondary Outcomes (2)

• Late toxicity

  open-ended

• Biochemical/clinicalprogression-free survival

  5 years

Study Arms (2)

Phase 1 Feasibility

Radiation: Proton Therapy; Radiation: IMRT

Phase 2 Registration

Radiation: Proton Therapy; Radiation: IMRT

Interventions

Proton Therapy RADIATION

Phase 1 Feasibility; Phase 2 Registration

IMRT RADIATION

Phase 1 Feasibility; Phase 2 Registration

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with non-metastatic adenocarcinoma of the prostate, presenting for definitive proton or photon radiotherapy of the prostate.

You may qualify if:

• Histologically confirmed prostate adenocarcinoma within 365 days of registration.
• Clinical stages T1a-T2c N0 M0 (AJCC Criteria 6th Ed). For any suspicious pelvic lymph node \> 1.5cm (as exhibited on pelvic imaging), biopsy of the lymph node is suggested.
• PSA values \<20 ng/ml within 90 days prior to registration, and done either prior to prostate biopsy, or at least 21 days after prostate biopsy.
• Zubrod (ECOG) status 0-1 documented within 90 days of registration.
• Androgen deprivation is at the discretion of the treating radiation oncologist.
• Subjects must give IRB-approved study-specific informed consent. Subjects must complete all required tests within the specified time frames.
• Subjects must be at least 18 years old.
• Members of all races and ethnic groups are eligible for this trial.

You may not qualify if:

• Clinical stages T3 or greater (AJCC Criteria 6th Ed).
• PSA of 20 ng/ml or greater.
• Gleason score 8 or higher.
• Evidence of distant metastasis. (Determined by CT scan, MRI, and/or bone scan prior to the simulation appointment; imaging results from UPHS will supercede results from similar scans from an outside facility.)
• Evidence of lymph node involvement.
• Previous prostate cancer surgery to include: prostatectomy, hyperthermia, and cryosurgery.
• Previous pelvic radiation for prostate cancer.
• Active rectal diverticulitis, Crohn's disease, or ulcerative colitis.
• Prior systemic chemotherapy for prostate cancer.
• History of proximal urethral stricture requiring dilatation.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (2)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Proton Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Neha Vapiwala, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 11, 2011
• Study Start: August 1, 2009
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

US (2)