Current partner codePEPTIDESDE
NCT03056638·Phase 3·INTERVENTIONAL

Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer

Status

Terminated

Phase

Phase 3

Enrollment

56

Locations

10

Results

Posted

Publications

0

Study summary

What the protocol is testing.

Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that allows the physician to deliver more radiation dose in a single session. Because of this, the number of radiation sessions can be reduced from the typical 45-48 sessions, as in conventional daily session radiation, to 5 sessions given every other day over a week and a half. Giving the radiation at a higher dose during each treatment may be more effective in killing the prostate cancer cells than the standard way of using external radiation therapy where a small amount of radiation is given over many sessions. Androgen Deprivation Therapy (ADT) or hormonal therapy is one of the methods to treat intermediate risk prostate cancer. This therapy works by reducing the level of testosterone and stopping them from affecting your cancer. The ADT used in this study is known as Degarelix. Degarelix is an approved medication that reduces the body's production of testosterone; this medication is usually given to all men with intermediate risk prostate cancer getting external radiation. This study is a randomized study to find out whether combining stereotactic (also known as precision) radiation to the prostate cancer combined with a short course of Degarelix will result in a greater likelihood of killing the cancer in the prostate compared to stereotactic radiation therapy given alone. It has been shown that the combination of radiation with medications that interfere with testosterone production and its effects makes prostate cancer cells more sensitive to the radiation.

Interventions

Treatment arms and agents.

DRUG

Degarelix

Degarelix monthly for 6 months

RADIATION

stereotactic body radiosurgery (SBRT)

SBRT 8 Gy x 5

Timeline

From registration to results.

  1. First posted

    Feb 17, 2017

  2. Study start

    Mar 28, 2017

  3. Primary completion

    Aug 16, 2023

  4. Study completion

    Aug 16, 2023

  5. Results posted

    Aug 28, 2024

  6. Registry updated

    Aug 28, 2024

Outcomes

What the study measures.

Primary outcomes

Number of Patients With a Positive Biopsy

Time frame · 2 years

compare 2-year biopsy positivity rate of intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

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

Inclusion Criteria: * Biopsy proven intermediate risk prostate cancer, which includes patients with any one of the following variables: * Gleason 7 disease * PSA 10-20 ng/ml * Clinical T2b-T2c disease Note: Patients who only have radiographic evidence of T3 disease (i.e. extracapsular extension, or seminal vesical invasion radiographically) will not be excluded. * Serum testosterone ≥ 240 ng/dL determined within 2 months prior to enrollment * At least 4 weeks must have elapsed from major surgery * KPS ≥ 80% * Prostate size as determined on MRI to be \< 90 cc. Prostate size can be determined on CT scan if MRI is not available. * 18 years of age or older * IPSS ≤ 20 * Patient must be available for follow-up. After 2 years of follow-up following post-treatment biopsy, telephone-based follow-up will be acceptable * Laboratory test findings within 8 weeks of randomization: * Adequate hepatic function with serum bilirubin ≤ 1.5 times the upper institutional limits of normal (ULN), ALT and AST ≤ 2.5 x ULN. Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is \< 3 mg/dL with a predominance of indirect bilirubin * Adequate renal function with serum creatinine ≤ 1.5 x ULN * Adequate hematologic function with absolute neutrophil counts ≥ 1,500 cell/mm3 and platelets ≥ 100,000 cells/mm3 and hemoglobin value ≥ 9 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value ≥ 9 g/dL with blood transfusions are allowed) Exclusion Criteria: * CT or MRI evidence of metastatic disease to the bone. * Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT * Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer (except for prior TURP or greenlight PVP which would be allowed) * History of another malignancy within the previous 3 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years * Patients with Crohn's disease or ulcerative colitis

Study locations

10 registered sites.

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

Baptist Alliance MCI

Miami, Florida, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Publications

Results and literature.

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

Primary links

Continue at the source.

Related trials

More studies on Degarelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.