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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: Hypofractionated pelvic External beam radiation; Radiation: Brachytherapy; Biological: Androgen deprivation therapy (ADT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05100472

21-405

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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 ≤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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Hormone Therapy and Radiation

Experimental group

Description:

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.

Treatment:

Radiation: Brachytherapy

Biological: Androgen deprivation therapy (ADT)

Radiation: Hypofractionated pelvic External beam radiation