Proton Radiation Therapy in Treating Patients With Prostate Cancer

NCT01045226 | Terminated DMC

• 2 other identifiers: UPCC 08809NCI-2009-01500
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating patients with prostate cancer.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility

  5 years

• Acute toxicity as assessed by NCI CTC Version 3.0

  90 days

Secondary Outcomes (2)

• Late toxicity as assessed by RTOG/EORTC late morbidity scoring system

  90 days

• Biochemical/clinical progression-free survival

  Time from start of radiotherapy to either documented increase in PSA or clinical progression of disease, death due to any cause or last patient contact alive

Study Arms (1)

Arm I

EXPERIMENTAL

Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity.

Procedure: Proton Beam Radiation Therapy; Other: Quality-of-Life assessment; Other: Questionnaire Administration

Interventions

Proton Beam Radiation Therapy PROCEDURE

Proton Beam Radiation Therapy

Arm I

Quality-of-Life assessment OTHER

Quality of Life Assessment

Arm I

Questionnaire Administration OTHER

Questionnaire Administration

Arm I

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed prostate adenocarcinoma within 365 days of registration
• Clinical stages T1a-T2a N0 M0
• For any pelvic lymph node \>= 1.5cm, biopsy of the lymph node is mandatory
• PSA values \< 10 ng/ml within 90 days prior to registration, done either prior to prostate biopsy or at least 21 days after prostate biopsy.
• Alkaline phosphatase within 60 days prior to registration. If alkaline phosphatase is elevated \> 2 x the upper limit of institutional normal (UNL), patient must have radiological correlation to assess for metastases
• Zubrod status 0-1 documented within 60 days of registration
• Prior androgen deprivation is allowed; however, androgen deprivation will not be continued concurrently or as an adjuvant therapy
• Patients must give IRB-approved study-specific informed consent
• Patients must complete all required tests listed within the specified time frames
• Patients must be able to start treatment within 56 days of registration
• Members of all races and ethnic groups are eligible for this trial

You may not qualify if:

• Clinical stages T2c or greater
• PSA of 10 ng/ml or greater
• Gleason score 7 or higher
• Evidence of distant metastasis
• Evidence of lymph node involvement
• Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery
• Previous pelvic radiation for prostate cancer
• Androgen deprivation therapy prior to radiation is allowed; however, it is not acceptable if continued during radiation or as adjuvant therapy
• Active rectal diverticulitis, Crohn's disease, or ulcerative colitis are not allowed
• Prior systemic chemotherapy for prostate cancer
• History of proximal urethral stricture requiring dilatation

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 8, 2010
• Study Start: August 1, 2009
• Primary Completion: December 1, 2020
• Study Completion: March 17, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

US (1)