- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03748719
Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The radiation will be given for only 5 days.
The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
- Histologically proven prostate adenocarcinoma.
- Clinical stage ≤T3a based on digital rectal exam (DRE) and ≤T3a based on MRI (within 3 months); N0-Nx; M0-Mx, or Gleason score 4 + 4. No more than 1 lymph node >1 cm.
- PSA ≤ 50 ng/ml, obtained within 3 months
- Prostate volume: ≤60 cc.
- IPSS score ≤15.
- No previous radiotherapy to the prostate or lower pelvis.
- Lymph node risk of <35% using https://www.mskcc.org/nomograms/prostate/pre_op.
- No prior radical prostatectomy or cryotherapy of the prostate (prior transurethral resection or laser ablation are permitted).
- No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
- No history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 3 years.
- No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy.
- Participant must be able to have gold fiducial markers placed in the prostate. Note: patients can be enrolled after fiducial markers have been placed, as long as the procedure was done in accordance with the protocol (Section 4.2.2).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Ability to understand and the willingness to sign a written informed consent document.
- Willing to fill out quality of life questionnaires.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Stereotactic Body Radiation Therapy, followed by Prostatectomy
Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.
|
SBRT treatment
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Measure of PSA (Prostate Specific Antigen)
Tidsramme: Up to 12 months
|
Measure of PSA through treatment.
PSA is expected to be undetectable (<0.2 mg/ml) after prostatectomy and radiation therapy.
|
Up to 12 months
|
Number of symptomatic adverse anastomotic events
Tidsramme: Up to 12 months
|
Number of symptomatic anastomotic events related to pre-operative SBRT.
|
Up to 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mean Catheterization Time
Tidsramme: Up to 4 weeks post surgery
|
Average time of catheterization following prostatectomy
|
Up to 4 weeks post surgery
|
Mean Hospital Stay
Tidsramme: Up to 2 week post surgery
|
Average time of hospitalization after prostatectomy
|
Up to 2 week post surgery
|
Quality of Life assessment
Tidsramme: Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery
|
Quality of Life will be assessed using 2 questionnaires: International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM).
The IPSS is an eight question questionnaire of symptoms ranging from 0 "not at all" to 5 "always".
The SHIM is a five question questionnaire ranging from 1 "almost never or never" to 5 "almost always or always" to determine erectile dysfunction.
|
Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Peter Johnstone, MD, H. Lee Moffitt Cancer Center and Research Institute
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MCC-19670
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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