Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

Clinicaltrials.gov ID: NCT01492972
db-list-check Status RECRUITING
b-loader Phase PHASE3
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 192

Conditions

Prostate Cancer

Drugs

Androgen Suppression Therapy

Summary

The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer.Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease. The benefit of the combination with androgen suppression is not completely understood. This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

Locations

4 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • : Clinical Trials Office - All Mayo Clinic Locations
  • 855-776-0015 (toll free)

Principal Investigator

  • Carlos Vargas, MD

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Carlos Vargas, MD

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Carlos Vargas, MD

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Carlos Vargas, MD

Eligibility Criteria

Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA > = 10 and < = 20, T stage T2b - T2c
* Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III).
* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. > 6 cores are strongly recommended.
* PSA values < = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.
* ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.
* Patients must sign IRB approved study specific informed consent.
* Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
* Patients must be able to start treatment within 56 days of randomization.
* Patients must be at least 18 years old.
* For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve urination.
* For brachytherapy, prostate volume must be less than 55cc prior to AS.

Exclusion Criteria:

* Pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
* Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
* Previous pelvic radiation for prostate cancer.
* Previous androgen suppression therapy for prostate cancer.
* Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
* Prior systemic chemotherapy for prostate cancer.
* History of proximal urethral stricture requiring dilatation.
* Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed).
* Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study).
* Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).
* History of myocardial infarction within the last 6 months.

Study Plan

Radiation Alone

ACTIVE_COMPARATOR

Proton Radiation Total Dose=70 Gy(RBE) OR High Dose Radiation with IMRT Alone=81 Gy OR Intraoperative LDR Brachytherapy and IMRT=45 Gy

  • RADIATION:

    Radiation

    Description:

    Consists of:nn1. Conformal Proton Radiation Dose: 2.5 Gy (RBE) five days a week in 28 treatments over 5.5-6.5 weeks (total dose: 70 Gy (RBE))n2. High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy)n3. Intraoperative LDR Brachytherapy and IMRT: 100Gy Pad103 implant and IMRT 1.8 Gy five days a week in 25 treatments over 5-6 weeks (total dose: 45 Gy)

Radiation + Androgen Suppression

EXPERIMENTAL

Androgen Suppression Therapy x 6 months + Radiation

  • RADIATION:

    Radiation

    Description:

    Consists of:nn1. Conformal Proton Radiation Dose: 2.5 Gy (RBE) five days a week in 28 treatments over 5.5-6.5 weeks (total dose: 70 Gy (RBE))n2. High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy)n3. Intraoperative LDR Brachytherapy and IMRT: 100Gy Pad103 implant and IMRT 1.8 Gy five days a week in 25 treatments over 5-6 weeks (total dose: 45 Gy)
  • DRUG:

    Androgen Suppression Therapy

    Description:

    Androgen suppression will begin 8 - 10 weeks prior to the start of RT for a total of 6 (+/- 2) months. Luteinizing Hormone-Releasing Hormone (LHRH) agonist therapy will consist of analogs approved by the FDA (or by Health Canada for Canadian institutions)

Outcome Measures

Primary Outcome Measures

Morbidity Outcomes

Time Frame: after the initial 100 patients have had a median follow up of at least three years and then every year.

Secondary Outcome Measures

Frequency and severity of grade 2 or higher GU and GI toxicity

Time Frame: At 6 months

Frequency and severity of GI and GU toxicity

Time Frame: At 3 years

Incidence of quality of life issues

Time Frame: At completion of radiation therapy

Incidence of Freedom from biochemical failure (FFBF)

Time Frame: At 5 years

Incidence of clinical failure: local and/or distant

Time Frame: At 5 years

Incidence of salvage Androgen Suppression use (SAD)

Time Frame: At 5 years

Incidence of progression free survival: using clinical, biochemical and SAD as events

Time Frame: At 5 years

Incidence of overall survival

Time Frame: At 5 years

Incidence of disease-specific survival

Time Frame: At 5 years

Correlate pathologic and radiologic findings with outcomes

Time Frame: At 5 years

Correlate PSA and free PSA levels with outcomes

Time Frame: At 5 years

Correlate testosterone levels and variation with proton therapy and outcomes

Time Frame: At 5 years

Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity

Time Frame: At 3 years

Timeline

  • Last Updated
    June 3, 2024
  • Start Date
    December 15, 2011
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    Not available

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