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Tests treatment safety and results for Intraprostatic Prostate Cancer
Official title Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)
ClinicalTrials.gov ID: NCT07142967
What this study is testing
What is Androgen Deprivation Therapy (ADT)?
Androgen Deprivation Therapy (ADT) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for intraprostatic prostate cancer.
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 assess the impact of prostate-specific membrane antigen/positron emission tomography (PSMA/PET)-informed magnetic resonance (MR)-guided radiation therapy on serious toxicity outcomes in patients with biopsy-proven locally radiorecurrent prostate cancer. The primary aim is to evaluate the safety of delivering MR-Linac-guided stereotactic body radiotherapy (SBRT) after prior prostate external beam radiotherapy for recurrent disease, and assess urinary toxicity outcomes at 2 years.
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
- 18 years of age or older male participants
- Biopsy proven intraprostatic prostate cancer after prior definitive external beam radiotherapy (moderate hypofractionation or Stereotactic Body...
- Pathology confirming recurrent disease must have evidence of viable cancer as indicated with pathology interpretation where a Gleason score can be...
- Serum testosterone ≥ 50 ng/dL determined within 2 months prior to enrollment a. Prior Androgen Deprivation Therapy (ADT) use acceptable if...
- At least 4 weeks must have elapsed from major surgery
You likely can't join if
- History of prostate brachytherapy (low dose rate or high dose rate)
- Actively undergoing androgen deprivation therapy and/or anti-androgens at time of enrollment
- CT or MRI or PET scan evidence of extraprostatic disease
- Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan
- History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer...
- Patients with Crohn's disease or ulcerative colitis
See the full eligibility criteria
- 18 years of age or older male participants
- Biopsy proven intraprostatic prostate cancer after prior definitive external beam radiotherapy (moderate hypofractionation or Stereotactic Body Radiation Therapy (SBRT) acceptable). a. NOTE: Seminal vesicle involvement...
- Pathology confirming recurrent disease must have evidence of viable cancer as indicated with pathology interpretation where a Gleason score can be assigned
- Serum testosterone ≥ 50 ng/dL determined within 2 months prior to enrollment a. Prior Androgen Deprivation Therapy (ADT) use acceptable if testosterone level \>50ng/dL
- At least 4 weeks must have elapsed from major surgery
- Karnofsky Performance Scale (KPS) ≥ 80% or Eastern Cooperative Oncology Group (ECOG) 0-1
- Prostate size as determined on MRI to be \< 90 cc.
- International Prostatism Symptom Score (IPSS) ≤ 20
- Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone, and chart review-based follow-up will be acceptable for up to 5 years
- Presence of a T2 and/or DWI-visible prostatic lesion on mpMRI a. NOTE: Lesion visible on MRI required for enrollment but PSMA/PET avid lesion not required
- Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
- History of prostate brachytherapy (low dose rate or high dose rate)
- Actively undergoing androgen deprivation therapy and/or anti-androgens at time of enrollment
- CT or MRI or PET scan evidence of extraprostatic disease
- Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan
- History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other...
- Patients with Crohn's disease or ulcerative colitis
- MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration...
- Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
- Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction
- Contra-indications to receiving gadolinium contrast or PSMA radioligand
- Karnofsky Performance Scale (KPS) \< 80 or ECOG 2+
- Grade 3 or higher toxicity experienced after the initial course of External Beam Radiation Therapy (EBRT)
- Disease free interval \< 2 years
- Hx of Transurethral Resection Of Prostate (TURP) within the year
- Prior high-intensity focused ultrasound (HIFU) or Cryotherapy
- Prior history of urethral stricture
- Unable to give informed consent
- Unable to complete quality of life questionnaires
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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 New York, New York, 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.