Prostate Cancer
Conditions
Keywords
Hypofractionated Pelvic Radiation, Brachytherapy Boost, NCCN High-Risk Prostate Cancer, Low-Intermediate Risk Decipher Genomic Score, Androgen Deprivation, 21-405
Brief summary
The purpose of this study is to find out whether combining a shorter than standard course of ADT with standard prostate brachytherapy and hypofractionated external beam radiation therapy is a safe and effective way to prevent high-risk prostate cancer from coming back and/or spreading to other parts of the body.
Interventions
BIOLOGICALAndrogen deprivation therapy (ADT)
ADT will include bicalutamide 50 mg PO daily started 1-2 weeks before leuprolide 22.5mg IM or SQ delivered every 3 months x 2. Bicalutamide will be continued through radiation and then discontinued on the day of the last fraction. Leuprolide can be given at different doses, but must be given for a total planned duration of 6 months.
RADIATIONBrachytherapy
After approximately 3 months (+/- 1 month) of neoadjuvant ADT, patients will undergo general anesthesia for outpatient transperineal high dose rate (HDR) interstitial prostate brachytherapy implant.
RADIATIONHypofractionated pelvic External beam radiation
Patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a phase II single arm trial.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically-proven diagnosis of prostate adenocarcinoma * Clinical stage T3-4 or Gleason score 8-10 or PSA \>20 ng/ml °If radiographic T3-T4 is the only high-risk factor, it must be consistent with or \>90% probability of having T3-T4 disease determined by the reading radiologist. * Decipher genomic score ≤0.6 * Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) * Age ≥18 * KPS ≥70 or ECOG 0-2 * Estimated life expectancy \>5 years * Baseline prostate volume ≤90 cc * Baseline IPSS ≤20 * No contraindications to ADT, brachytherapy, or pelvic external beam radiation therapy as determined by the treating radiation oncologist per standard practice * Patients who have already started ADT consisting of bicalutamide 50 mg PO daily with leuprolide or an equivalent GnRH analogue are eligible if given for ≤ 60 days prior to registration
Exclusion criteria
* Regional lymph node or metastatic disease * Prior pelvic radiation * Prior prostate surgery (including TURP or cryosurgery) * Prior history of inflammatory bowel disease * Unable to undergo anesthesia or brachytherapy * Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distant metastatic disease-free (DMF) rate | 3 years | Time to distant metastases will be estimated from the date of enrollment until distant metastases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological response rate | Between 24-36 months after radiation | — |
| Cumulative incidence of biochemical failure | 3 years | — |
| Overall survival rate | 3 years | — |
| Acute and late physician-scored toxicity | 3 years | Using CTCAE v5.0. NCI Common Toxicity Criteria. The NCI scales are simple to complete and provide a means for assessing patient symptoms. Only the CTCAE v 5.0 will be used in toxicity grading. |
Countries
United States
Outcome results
None listed