ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase III Randomized Trial Comparing Short Course Androgen Deprivation Therapy And Ultra-Hypofractionated SBRT Versus Ultra-Hypofractionated SBRT Alone For Unfavorable Intermediate Risk Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397703
• Other study ID #: 23-01267
• Status: Recruiting
• Phase: Phase 3
• Start date: April 16, 2024
• Est. completion date: April 16, 2028

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Dayna Leis, RN
• Phone: 347-266-2630
• Email: Dayna.Leis[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For this proposed Phase III study, unfavorable intermediate risk prostate cancer patients will be randomized to receive 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus SBRT alone. The patient population will include those with National Comprehensive Cancer Network (NCCN)-defined unfavorable intermediate risk disease. All patients will be followed every 6 months for up to 5 years from the first patient randomized and will undergo a routine 24-30 months post-SBRT prostate biopsy to assess for local tumor control.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 392
• Est. completion date: April 16, 2028
• Est. primary completion date: April 16, 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Biopsy proven unfavorable intermediate risk prostate cancer, which includes patients with any one of the following variables: Gleason 4+3 disease; Percent positive cores > 50% of Gleason 7 disease; 2-3 intermediate risk factors (Gleason 7; PSA 10-20 ng/mL; or T2b-T2c)

• Patients must have tissue available for Decipher score testing. Results must be available before randomization.

• Serum testosterone = 150 ng/dL determined within 2 months prior to enrollment

• At least 4 weeks must have elapsed from major surgery

• Karnofsky Performance Scale (KPS) = 80%

• Prostate size as determined on MRI to be < 90 cc. Prostate size can be determined on CT scan if MRI is not available

• IPSS = 20

• Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone and chart review-based follow-up will be acceptable

• Adequate hepatic function with serum bilirubin less than or equal to 1.5 times the upper institutional limits of normal (ULN), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to 2.5 x ULN. Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin

• Adequate renal function with serum creatinine less than or equal to 1.5 x ULN

• Adequate hematologic function with absolute neutrophil counts of at least 1,500 cell/mm3 and platelets of at least 100,000 cells/mm3 and hemoglobin value > 9 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value > 9 g/dL with blood transfusions are allowed).

Exclusion Criteria:

• CT or MRI or Positron Emission Tomography (PET) scan evidence of metastatic disease to the bone

• Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan

• Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer (except for prior (transurethral resection of prostate) TURP or greenlight (photoselective vaporization of prostate) PVP which would be allowed)

• History of another malignancy within the previous 2 years except for the following:

adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years

• Patients with Crohn's disease or ulcerative colitis

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Leuprolide, Degarelix or Relugolix
Patients assigned to the androgen deprivation therapy (ADT) arm will be treated with monthly Degarelix, or Leuprolide injections or daily Relugolix pills which are all standard ADT interventions.

Radiation:
• Stereotactic body radiation therapy/radiosurgery (SBRT)
SBRT will be directed to the prostate and delivered with a prescription dose of 40 Gy in 5 fractions prescribed to the 95% isodose line encompassing the planning target volume. Inter-fraction motion targeting and target position corrections will be utilized for each of the 5 treatment fractions.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-Free Survival	Defined as the percentage of participants who survive without any signs or symptoms of prostate cancer.	Up to Year 5
Secondary	Incidence of Biochemical Failure	Biochemical failure recurrence will be determined according to the established Phoenix criteria of 2 ng/nl elevation of the prostate specific antigen (PSA) nadir level (nadir + 2 definition).	Up to Year 5
Secondary	Incidence of Distant Metastases	Number of distant metastases observed over the course of the study.	Up to Year 5
Secondary	Overall Survival	Defined as the length of time from the date of randomization until death.	Up to Year 5
Secondary	Number of Positive Post-Treatment Biopsies		Year 2 Post-Treatment (Month 24-30)
Secondary	Change in Expanded Prostate Cancer Index Composite (EPIC) Questionnaire Score	32-item assessment of prostate cancer symptoms. Late bowel function as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC) sub-domain approximately 1 year after the end of treatment. The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The values vary from 0 to 100 for each question. The scores are averaged to derive a quality of life score, ranging from 0-100.	Baseline, Year 2
Secondary	Change in International Prostatism Symptom Score (IPSS)	7-item questionnaire of benign prostatic hyperplasia (BPH) symptoms. Each item is rated on a scale from 0 (not at all) to 5 (almost always). The total score is the sum of responses and ranges from 0 to 35; higher scores indicate greater BPH symptomology.	Baseline, Year 2
Secondary	Change in 12-Item Short Form Health Survey (SF-12) Score	The SF-12 is a 12-item assessment of the impact of health on an individual's everyday life. The total score is the sum of each item and is standardized; the total score ranges from 0 to 100, with higher scores indicated better physical and mental health functioning.	Baseline, Year 2