Primary outcome· 2 years
Number of Patients With a Positive Biopsy
| Group | Value |
|---|---|
| Degarelix in Conjunction With Stereotactic Body Radiosurgery | not posted |
| Stereotactic Body Radiosurgery (SBRT) | not posted |
Trial · Interventional
TerminatedPhase 3Results postedRegistry dataTrial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer
NCTNCT03056638 (opens ClinicalTrials.gov in a new tab)Other id16-1686
This trial was stopped early.
Reason given at the registry: Due to low accrual
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 3
- Enrollment
- 56 participants (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 28 Mar 2017
- Primary completion
- 16 Aug 2023
- Completion
- 16 Aug 2023
- First posted
- 17 Feb 2017
- Last update posted
- 28 Aug 2024
- Conditions
- Prostate Cancer
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2018202020222024
- Ph 3Terminated
Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer
NCT0305663828 Mar 2017 to 16 Aug 2023
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
- DegarelixDrug
- stereotactic body radiosurgery (SBRT)Radiation
Arms2
Experimental
Degarelix in conjunction with stereotactic body radiosurgery
Degarelix monthly for 6 months SBRT 8 Gy x 5
Experimental
stereotactic body radiosurgery (SBRT)
SBRT 8 Gy x 5
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Patients With a Positive Biopsy
Time frame · 2 years
Registry description
compare 2-year biopsy positivity rate of intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Degarelix in Conjunction With Stereotactic Body RadiosurgeryDegarelix monthly for 6 months SBRT 8 Gy x 5 Degarelix: Degarelix monthly for 6 months stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5 | 1 / 27 | 1 / 27 | 2 / 27 |
| Stereotactic Body Radiosurgery (SBRT)SBRT 8 Gy x 5 stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5 | 0 / 29 | 0 / 29 | 0 / 29 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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