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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05100472
• Other study ID #: 21-405
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 19, 2021
• Est. completion date: October 19, 2025

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 19, 2025
• Est. primary completion date: October 19, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distant metastatic disease-free (DMF) rate	Time to distant metastases will be estimated from the date of enrollment until distant metastases	3 years
Secondary	Pathological response rate		Between 24-36 months after radiation
Secondary	Cumulative incidence of biochemical failure		3 years
Secondary	Overall survival rate		3 years
Secondary	Acute and late physician-scored toxicity	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.	3 years

External Links

•   Memorial Sloan Kettering Cancer Center