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New treatment option for Prostate Cancer
Official title Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
ClinicalTrials.gov ID: NCT01492972
What this study is testing
What is Androgen Suppression Therapy?
Androgen Suppression Therapy is an investigational medicine, being studied as a potential treatment for prostate cancer.
Also referred to as leuprolide, goserelin, buserelin, or triptorelin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one...
- 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...
- 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.
You likely can't join if
- 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...
- Prior systemic chemotherapy for prostate cancer.
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Warrenville, Illinois, United States
- Oklahoma City, Oklahoma, United States
- Hampton, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Warrenville, Illinois, United States; Oklahoma City, Oklahoma, United States; Hampton, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.