Intraprostatic Prostate Cancer
Conditions
Keywords
prostate adenocarcinoma
Brief summary
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.
Interventions
RADIATIONStereotactic Body Radiation Therapy (SBRT)
SBRT will be delivered with a prescription dose of 8 Gy x 5 fractions prescribed to the 95% isodose line encompassing the dominant recurrent intraprostatic lesion (DRIL) as seen on MRI and/or PET PSMA imaging plus 4mm (GTV+4mm=CTV\_40). Remainder of the prostate gland minus CTV\_40 (CTV\_25) will be prescribed to 5 Gy x 5 fractions at the 95% isodose line.
DRUGAndrogen Deprivation Therapy (ADT)
ADT would be given 0-1 months prior to planned SBRT to the prostate for total of 4-6 months. ADT will be administered via Leuprolide or Degarelix monthly injections or daily Relugolix pills.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older male participants 2. 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 allowed 3. Pathology confirming recurrent disease must have evidence of viable cancer as indicated with pathology interpretation where a Gleason score can be assigned 4. 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 5. At least 4 weeks must have elapsed from major surgery 6. Karnofsky Performance Scale (KPS) ≥ 80% or Eastern Cooperative Oncology Group (ECOG) 0-1 7. Prostate size as determined on MRI to be \< 90 cc. 8. International Prostatism Symptom Score (IPSS) ≤ 20 9. 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 10. 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 11. Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
Exclusion criteria
1. History of prostate brachytherapy (low dose rate or high dose rate) 2. Actively undergoing androgen deprivation therapy and/or anti-androgens at time of enrollment 3. CT or MRI or PET scan evidence of extraprostatic disease 4. Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan 5. 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 cancer that has been in complete remission for at least 3 years 6. Patients with Crohn's disease or ulcerative colitis 7. 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 of the study; etc. 8. Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI 9. Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction 10. Contra-indications to receiving gadolinium contrast or PSMA radioligand 11. Karnofsky Performance Scale (KPS) \< 80 or ECOG 2+ 12. Grade 3 or higher toxicity experienced after the initial course of External Beam Radiation Therapy (EBRT) 13. Disease free interval \< 2 years 14. Hx of Transurethral Resection Of Prostate (TURP) within the year 15. Prior high-intensity focused ultrasound (HIFU) or Cryotherapy 16. Prior history of urethral stricture 17. Unable to give informed consent 18. Unable to complete quality of life questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late toxicity (after 90 days) radiation-associated genitourinary (GU) and gastrointestinal (GI) events | Month 24 | A serious toxicity event will be defined as any Grade 3 or higher genitourinary or gastrointestinal toxicity, based on NCI CTCAE v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity (occurring within 90 days of the treatment) radiation-associated genitourinary (GU) and gastrointestinal (GI) events | Month 24 | A serious toxicity event will be defined as any Grade 3 or higher genitourinary or gastrointestinal toxicity, based on NCI CTCAE v5.0. |
| Biochemical progression free survival | Month 24 | From the time after treatment until the prostate-specific antigen (PSA) level rises, indicating a potential return of cancer. |
| Distant metastasis-free survival (DMFS) | Month 24 | Distant metastasis-free survival (DMFS) the time from end of treatment until the first instance of distant metastasis or death, whichever occurs first. |
| Radiographic treatment response rate of target intra-prostatic lesion | Month 24 | Radiographic treatment response rate is the patients whose tumors show a reduction in size or other measurable changes on imaging scans after receiving treatment. |
| Expanded Prostate cancer Index Composite (EPIC-26) Short Form score | Month 24 | The EPIC-26 short form scores range from 0 to 100 for each of its five domains (urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal). Higher scores indicate better health-related quality of life (HRQOL) within that domain. |
| International prostate symptom score index (IPSS) score | Month 24 | The IPSS index is a seven-item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six-point Likert scale, scores range from 0 to 35, with higher scores indicating more severe urinary symptoms. Scores are categorized as mild (0-7), moderate (8-19), or severe (20-35). |
| International Index of Erectile Function (IIEF) score | Month 24 | The IIEF 5 form is a 5-item questionnaire used to assess erectile function and diagnose erectile dysfunction (ED). Participant rate their responses using a 6-point Likert Scale (0-5). Scores range from 5 to 25. Scores are categorized as follows: 5-7 (severe ED), 8-11 (moderate ED), 12-16 (mild to moderate ED), 17-21 (mild ED), and 22-25 (no ED) |
Countries
United States
Contacts
CONTACTMichael Zelefsky, MD
PRINCIPAL_INVESTIGATORMichael Zelefsky, MD
NYU Langone Health
Outcome results
None listed