Prostate Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT05100472

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 7 Locations for this study

See Locations Near You

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale New York, 11553, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

50

Study ID:

NCT05100472

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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