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Active, Not Recruiting

NCT Number: NCT05100472

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Androgen deprivation therapy (ADT)

Biological

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.

Brachytherapy

Radiation

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

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.

Primary outcomes

  1. Distant metastatic disease-free (DMF) rate

    Time frame: 3 years

    Time to distant metastases will be estimated from the date of enrollment until distant metastases

Secondary outcomes

  1. Pathological response rate

    Time frame: Between 24-36 months after radiation

  2. Cumulative incidence of biochemical failure

    Time frame: 3 years

  3. Overall survival rate

    Time frame: 3 years

  4. Acute and late physician-scored toxicity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2021
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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