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Citrate

Placebo

testosterone gel applied 1x daily for 3 months

topical testosterone

Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Androxal

Larry Lipshultz, MD

The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.

This study is a phase IIb, 4 arm study with three month active dosing period. Three of the four treatment groups will be randomized to either Androxal or placebo in a double-blind fashion, and the fourth treatment group will receive open-label Testim. The doses of Androxal in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.

Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim

Changes in values from baseline in LH at month 3

Change from baseline in sperm concentration

Repros Therapeutics Inc.

Placebo

Placebo: Placebo capsule 1x daily for 3 months

Testim (topical testosterone)

topical testosterone: testosterone gel applied 1x daily for 3 months

Testim (Topical Testosterone)

Androxal 12.5 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Androxal 12.5 mg

Androxal 25 mg/day

Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Androxal 25 mg

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Jennifer L. Wike

Intent to treat subjects with an assessment after baseline

Change in Total Morning Testosterone

Change in Luteinizing Hormone Levels

Change in FSH After 3 Months of Treatment

Reproductive Safety

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Pluvicto

Radiopharmaceuticals

Metastasis directed therapy with stereotactic ablative radiotherapy to all detectable sites of disease plus PSMA radiopharmaceutical therapy and discontinuation of castration

Metastasis directed therapy with stereotactic ablative radiotherapy to all detectable sites of disease plus PSMA radiopharmaceutical therapy and discontinuation of castration, followed by restoration of physiologic testosterone

stereotactic ablative radiotherapy

PSMA targeted radiopharmaceutical therapy

Nicholas G Nickols, MD PhD

Matthew B Rettig, MD

Nicholas Nickols, MD

Nicholas George Nickols, MD PhD

This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer.

All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.

This is a randomized, parallel-arm, two-stage open-label phase 2 study of comprehensive metastasis directed therapy in the form of stereotactic body radiation therapy (SBRT) to all detectable sites of disease plus PSMA targeted radiopharmaceutical therapy (pluvicto), discontinuation of castration, with and without testosterone replacement therapy (TRT) in metastatic castration resistant prostate cancer (mCRPC).

Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc

Phase II Trial of Targeted Radiation With no Castration for Mcrpc

6-month radiographic progression-free survival (rPFS) measured by conventional imaging from date of initiation of PSMA radiopharmaceutical therapy

Physician reported Common Terminology Criteria for Adverse Events (CTCAE version 5.0)

EPIC-26 contains 26 items in 5 domains (Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal). Raw scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.

This is the rate of PSA response (PSA decrease by 30%, 50%, 90%), and maximal response

Time to PSA progression per PCWG3 criteria, from date of initiation of PSMA radiopharmaceutical therapy

Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) from date of initiation of PSMA radiopharmaceutical therapy

Time-to-event, Bone progression by Prostate Cancer Working Group 3 (PCWG3) criteria and/or soft tissue progression by RECIST v1.1, from date of initiation of PSMA radiopharmaceutical therapy

Measured using Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE)

Time-to-event, a composite between time to PSA progression (PCWG3) and/or radiographic progression (PCWG3 for bone, RECIST 1.1 for soft tissue), from date of initiation of PSMA radiopharmaceutical therapy

Time-to-event, from date of initiation of PSMA radiopharmaceutical therapy

FACT-P includes a general functional status scale (consisting of four subscales: physical wellbeing, social and family wellbeing, emotional wellbeing, and functional wellbeing) and a prostate-cancer-specific subscale. Total score is calculated with general function and prostate-cancer-specific scores, and ranges from 0 to 156 (higher scores indicate better functional status).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism	NCT01270841	Secondary Hypog...	Placebo topical testost... Androxal	21 Years - 65 Years	Repros Therapeutics Inc.
Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc	NCT06084338	Prostate Cancer	stereotactic ab... Pluvicto topical testost...	18 Years -	VA Office of Research and Development
Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc	NCT06084338	Prostate Cancer	stereotactic ab... Pluvicto topical testost...	18 Years -	VA Office of Research and Development
Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc	NCT06084338	Prostate Cancer	stereotactic ab... Pluvicto topical testost...	18 Years -	VA Office of Research and Development

Spots Global Cancer Trial Database for topical testosterone