Description:
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.
Title
- Brief Title: Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
- Official Title: Phase III Study of Image Guided Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate
Clinical Trial IDs
- ORG STUDY ID:
GU003-10
- NCT ID:
NCT01492972
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Androgen Suppression Therapy | leuprolide, goserelin, buserelin, or triptorelin | Radiation + Androgen Suppression |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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 + Androgen Suppression | Experimental | Androgen Suppression Therapy x 6 months + Radiation | - Androgen Suppression Therapy
|
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Morbidity Outcomes |
Time Frame: | after the initial 100 patients have had a median follow up of at least three years and then every year. |
Safety Issue: | |
Description: | To determine if androgen suppression along with radiation therapy will result in a higher freedom from failure (FFF) than radiation therapy without androgen suppression.
Freedom from failure (FFF): The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA) (45) discounting bounces per investigator discretion, or the start of salvage therapy including androgen suppression |
Secondary Outcome Measures
Measure: | Frequency and severity of grade 2 or higher GU and GI toxicity |
Time Frame: | At 6 months |
Safety Issue: | |
Description: | Assessment of grade 2 or higher GU and GI toxicity using CTCAE 4.0 criteria |
Measure: | Frequency and severity of GI and GU toxicity |
Time Frame: | At 3 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of quality of life issues |
Time Frame: | At completion of radiation therapy |
Safety Issue: | |
Description: | |
Measure: | Incidence of Freedom from biochemical failure (FFBF) |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of clinical failure: local and/or distant |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of salvage Androgen Suppression use (SAD) |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of progression free survival: using clinical, biochemical and SAD as events |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of overall survival |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of disease-specific survival |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | |
Measure: | Correlate pathologic and radiologic findings with outcomes |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | |
Measure: | Correlate PSA and free PSA levels with outcomes |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | |
Measure: | Correlate testosterone levels and variation with proton therapy and outcomes |
Time Frame: | At 5 years |
Safety Issue: | |
Description: | |
Measure: | Prospectively collect information that will help to define dose-volume relationships of normal structures with acute and chronic toxicity |
Time Frame: | At 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Proton Collaborative Group |
Trial Keywords
- Prostate
- proton
- radiation
- intermediate risk
Last Updated
July 12, 2019