Current partner codePEPTIDESDE
NCT01492972·Phase 3·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 3

Enrollment

192

Locations

4

Results

Not posted

Publications

0

Study summary

What the protocol is 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. 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.

Interventions

Treatment arms and agents.

RADIATION

Radiation

Consists of: 1. 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)) 2. High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy) 3. 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

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)

Timeline

From registration to results.

  1. First posted

    Dec 15, 2011

  2. Study start

    Jan 2012

  3. Primary completion

    Dec 2027

  4. Study completion

    Not reported

  5. Results posted

    Not reported

  6. Registry updated

    Sep 4, 2025

Outcomes

What the study measures.

Primary outcomes

Morbidity Outcomes

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

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 outcomes

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

Time frame · At 6 months

Assessment of grade 2 or higher GU and GI toxicity using CTCAE 4.0 criteria

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
MALE
Healthy volunteers
No

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 locations

4 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Mayo Clinic

Scottsdale, Arizona, United States

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois, United States

Oklahoma Proton Center

Oklahoma City, Oklahoma, United States

Hampton University Proton Therapy Institute

Hampton, Virginia, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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