Proton Therapy for High Risk Prostate Cancer

NCT01811810 | Withdrawn DMC

• 1 other identifier: UPCC 22812
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The most common treatment for men with high risk prostate cancer is radiation therapy (XRT) followed by long term androgen deprivation therapy (ADT). Long-term AD is toxic, with substantial metabolic, physical, mental and sexual side-effects. In this study, the investigators propose a treatment strategy to optimize the control of high risk prostate cancer by using dose-escalated external beam radiation (proton therapy or IMRT) concurrent with docetaxel and adjuvant short-course AD. The investigators hypothesize that this approach will be superior to the current standard of care and obviate the need for long term AD. In this study, subjects will be randomized to either XRT with long term ADT or XRT and chemotherapy and short term ADT.

Conditions

Prostate Cancer

Keywords

Men under the age of 75 with histologically confirmed high risk

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  5 years

Study Arms (2)

xrt and long term ADT

OTHER

Radiation therapy (XRT) and long term androgen deprivation therapy

Radiation: Radiation therapy (XRT); Other: Androgen Deprivation Therapy (ADT)

xrt, chemotherapy and short term ADT

OTHER

radiation therapy (XRT), chemotherapy and short term ADT

Radiation: Radiation therapy (XRT); Other: Androgen Deprivation Therapy (ADT); Other: Chemotherapy

Interventions

Radiation therapy (XRT) RADIATION

xrt and long term ADT; xrt, chemotherapy and short term ADT

Androgen Deprivation Therapy (ADT) OTHER

xrt and long term ADT; xrt, chemotherapy and short term ADT

Chemotherapy OTHER

xrt, chemotherapy and short term ADT

Eligibility Criteria

• Age: 18 Years - 75 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 randomization).
• High-risk for recurrence as determined by evidence of at least one of the following: Gleason Score 8-10 PSA 20 T stage T3
• Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-10. 6 cores are strongly recommended.
• Clinical stages T1a- T3 N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.-appendix III).
• PSA values 50 ng/ml within 90 days prior to randomization. Must be completed prior to biopsy or at least 21 days after prostate biopsy.
• Absolute Neutrophil Count (ANC) 1,800 cells/mm³ within 90 days prior to randomization.
• Platelets 100,000 cells/mm³ within 90 days prior to randomization.
• Hemoglobin 10 g/dl within 90 days prior to randomization. 3.1.9 ALT, AST, and total bilirubin within 1.5 X institutional upper normal limits within 90 days prior to randomization.
• ECOG status 0-1 (appendix II) documented within 90 days of randomization.
• Patient must sign study specific informed consent prior to randomization. Note: consent for legally authorized representative is not permitted.
• Completed all requirements listed in section 4.0 within the specified time frames.
• Able to start treatment within 56 days of randomization.
• At least 18 years old and less than or equal to 75 years of age.
• Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards.
• Medical oncology consultation prior to randomization and medically approved for chemotherapy treatment per protocol.

You may not qualify if:

• Evidence of distant metastasis.
• Pelvic lymph nodes 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
• Prior prostate cancer surgery including but not limited to prostatectomy, hyperthermia and cryosurgery.
• Prior pelvic radiation for their prostate cancer.
• Prior androgen suppression.
• Severe, active co-morbidity, defined as follows:
• Active rectal diverticulitis, Crohns disease affecting the rectum or ulcerative colitis. (Non-active diverticulitis and Crohns disease not affecting the rectum are allowed).
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
• Myocardial infarction within the last 6 months.
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization.
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
• Prior allergic reaction to the drugs involved in this protocol.
• Existing peripheral neuropathy grade 2.
• 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

Related Publications (1)

• Guttilla A, Bortolus R, Giannarini G, Ghadjar P, Zattoni F, Gnech M, Palumbo V, Valent F, Garbeglio A, Zattoni F. Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial. Radiat Oncol. 2014 Jan 14;9:24. doi: 10.1186/1748-717X-9-24.

  PMID: 24423462 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy; Androgen Antagonists; Drug 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)

Therapeutics; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• John Christodouleas, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 15, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

US (1)