A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05100472

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

7.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Biological: Androgen deprivation therapy (ADT) Radiation: Brachytherapy Radiation: Hypofractionated pelvic External beam radiation	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a phase II single arm trial.This is a phase II single arm trial.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Short Course Androgen Deprivation, Hypofractionated Pelvic Radiation and a Brachytherapy Boost for NCCN High-Risk Prostate Cancer With Low-Intermediate Risk Decipher Genomic Score

Actual Study Start Date :

Oct 19, 2021

Anticipated Primary Completion Date :

Oct 19, 2024

Anticipated Study Completion Date :

Oct 19, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hormone Therapy and Radiation Patients enrolled in this study will receive ADT for 6 months which will consist of bicalutamide 50 mg PO daily starting approximately 1-2 weeks before leuprolide 22.5mg injected every 3 months. The HDR prostate brachytherapy procedure will be performed approximately 3 months after starting ADT to allow for potential radiosensitization and cytoreduction. Approximately 4 weeks after the HDR boost, 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.	Biological: Androgen 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. Radiation: Brachytherapy 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. Radiation: Hypofractionated 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.

Arm

Intervention/Treatment

Experimental: Hormone Therapy and Radiation

Patients enrolled in this study will receive ADT for 6 months which will consist of bicalutamide 50 mg PO daily starting approximately 1-2 weeks before leuprolide 22.5mg injected every 3 months. The HDR prostate brachytherapy procedure will be performed approximately 3 months after starting ADT to allow for potential radiosensitization and cytoreduction. Approximately 4 weeks after the HDR boost, 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.

Biological: Androgen 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.

Radiation: Brachytherapy

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.

Radiation: Hypofractionated 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.

Outcome Measures

Primary Outcome Measures

Distant metastatic disease-free (DMF) rate [3 years]
Time to distant metastases will be estimated from the date of enrollment until distant metastases

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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 ≤75 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York	United States	11553